Wellness Foods & Supplements 3/2020
Wellness Foods & Supplements is the first European magazine devoted exclusively to health ingredients, nutraceutical foods and beverages.
Wellness Foods & Supplements is the first European magazine devoted exclusively to health ingredients, nutraceutical foods and beverages.
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No. 3, November/December <strong>2020</strong><br />
www.harnisch.com | ISSN 2364-8104<br />
Nutrition and ageing Functional sugars Oils and fats Energy and endurance<br />
Minerals Women’s health Clinical trials Dairy Fortified dairy alternatives
Editorial<br />
SILKE WATKINS, Editor-in-Chief<br />
Social contacts – an elixir of life?<br />
Normally, I would have written the editorial<br />
for this issue in the run-up to Fi Europe<br />
and Hi Europe and would have been looking<br />
forward to the talks at the fair. However,<br />
unfortunately, everything is different this year<br />
and we are now experiencing a second lockdown<br />
that encroaches deeply on our normal<br />
lives.<br />
Trade fairs have been cancelled and how<br />
long we will have to wait in order to be able<br />
to present ourselves at a trade fair again and<br />
to have personal discussions is currently not<br />
foreseeable.<br />
In the editorial of issue 1, I already dealt with<br />
how this exceptional situation affects older<br />
people in particular, who depend on contact<br />
with other people because it is so important<br />
for their mental health. Politicians in<br />
particular have repeatedly emphasised that<br />
we have to protect the elderly. One would<br />
assume that one would have learned from<br />
the consequences of the initial lockdown<br />
and developed concepts. Unfortunately, I<br />
see next to nothing of that. It is still said that<br />
we have to massively restrict our contacts.<br />
Doesn't that inevitably mean that relatives,<br />
friends and acquaintances are again banned<br />
from visiting senior citizens?<br />
appeal to politicians. So residents in retirement homes should not be<br />
isolated again. The appeal contains, among other things, a demand<br />
for the right of home residents and their relatives to social contact, a<br />
right to touch, a right to protective clothing, a right to pastoral care<br />
and a right to privacy.<br />
This should make it possible to reconcile the right to self-determination<br />
and the free development of the personality on the one hand with<br />
the protection of life in the homes on the other.<br />
I think this appeal is very important and right. With all the challenges,<br />
we must not forget that a healthy life also requires social contacts,<br />
such as a friendly conversation, a touch, an open ear or a helping<br />
hand.<br />
In this issue, you will find out what we can do about our health in<br />
terms of nutrition or strengthening our immune system. I wish you an<br />
interesting read and a better year 2021.<br />
With kind regards<br />
Silke Watkins<br />
I just learned from the local press that<br />
pastors and old people's home chaplains<br />
are watching the stricter visiting rules in the<br />
homes with concern. They have made an<br />
No. 3 November/December <strong>2020</strong><br />
3
Contents<br />
Health<br />
Convenience Food<br />
Food & Beverages<br />
Confectionary<br />
Cover Photo © : AdobeStock/iONYXprj<br />
The number and proportion of people aged 60 years<br />
and older in the population is increasing. In 2019,<br />
the number of people aged 60 years and older was<br />
1 billion. This number will increase to 1.4 billion by<br />
2030 and 2.1 billion by 2050. Nowadays seniors<br />
actively seek to maintain good health in everyday<br />
life. Healthy ageing is the process of “developing<br />
and maintaining the functional ability that<br />
enables wellbeing in older age”. Seniors have<br />
specific nutritional needs (proteins, calcium,<br />
etc.) as they are more exposed to health issues.<br />
Despite this, they do not want to feel categorized<br />
and nutritional products must be indulgent and<br />
attractive.(see article at page 12)<br />
Sports Nutrition<br />
Health Care<br />
Contents<br />
Personal Care<br />
Oils and fats<br />
06 Keeping omega-3 oils safe, pure and taste-neutral<br />
Functional sugars<br />
10 Human milk oligosaccharides for health<br />
Nutrition and ageing<br />
12 Outstanding milk proteins & bioactives, allies of seniors<br />
Energy and endurance<br />
17 Be your best with Bioactive Collagen Peptides ®<br />
Minerals<br />
20 Magnesium Carbonate – Oldie but Goldie<br />
Women’s health<br />
23 Her ally for a healthy intimate flora<br />
Clinical trials<br />
28 Adaptive designs in clinical trials: when, why and how?<br />
Fortified dairy alternatives<br />
32 Mineral fortification in dairy alternatives<br />
Dairy products<br />
39 Yogurt Powders: the health benefits of yogurt with added convenience<br />
42 Impressum<br />
4 No. 3 November/December <strong>2020</strong>
HER ALLY FOR A<br />
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L. plantarum P17630 (Proge P17630 ® ),<br />
licensed from PROGE FARM ® , Italy.<br />
QUALITY PROBIOTICS.<br />
COMPLETE SOLUTIONS.
Oils and fats<br />
Photo © : 123rf/jirkaejc<br />
Keeping omega-3 oils safe, pure<br />
and taste-neutral<br />
Frank Möllering<br />
With the growing awareness of the health benefits of omega-3<br />
unsaturated fatty acids, demand for supplements, fortified<br />
foods and enriched beverages is rising. High-quality vegetable<br />
and microalgae-derived oils are particularly popular,<br />
but consumers are still sceptical about omega-3 products<br />
containing fish oil. Straight away, “fishy” smelling and<br />
tasting capsules come to mind. Yet, there are methods and<br />
processes available that refineries can use to supply highpurity<br />
oils that are absolutely neutral in terms of sensory<br />
properties.<br />
Although the number of people who still abide by the old dietary<br />
recommendation of eating fish at least once a week is declining,<br />
there is increasing evidence to illustrate just how important omega-3<br />
fatty acids are for our minds and bodies. For a long time, fatty fish<br />
and seafood such as mussels were said to be the most important<br />
sources; now, however, a huge array of dietary supplements are available<br />
on the market, and a growing number of<br />
foodstuffs and beverages are enriched with<br />
essential fatty acids. Fish is still a popular<br />
source of oil, but it’s a challenging material<br />
to process: it oxidises quickly and, like<br />
any crude oil of plant or animal origin, can<br />
become contaminated during cultivation<br />
or transport. Additionally, fish oil poses the<br />
greatest challenge in terms of neutralising<br />
its fishy odour and taste. Nutriswiss, a small<br />
refinery that specialises in purifying and<br />
modifying high-quality edible oils, has been<br />
processing fish oil for many years. Keeping<br />
a close eye on market developments at the<br />
same time, this Swiss company is well aware<br />
of the plant-based trend and now processes<br />
just as much algal oil as fish oil.<br />
6 No. 3 November/December <strong>2020</strong>
Oils and fats<br />
Growing demand for health<br />
and wellness<br />
To ensure a sufficient supply of essential fatty<br />
acids, alternatives to fish oil are in demand.<br />
In recent years, vegetable sources such as<br />
nuts, seeds and oils (such as rapeseed)<br />
have become increasingly popular; chia<br />
and linseed are frequently used as toppings<br />
in healthy bowls or shakes, for example.<br />
Compared with marine sources, they mainly<br />
contain the omega-3 fatty acid, ALA (alphalinolenic<br />
acid), which must be converted by<br />
human metabolism to DHA (docosahexaenoic<br />
acid) and EPA (eicosapentaenoic acid).<br />
As this is only partially possible and an inefficient<br />
process, the required intake is much<br />
higher.<br />
Long-chain omega-3 fatty acids play an<br />
important role in brain growth and development,<br />
blood pressure regulation, kidney function,<br />
blood clotting and numerous inflammatory<br />
and immunological reactions. A recent<br />
study showed that omega-3s can protect the<br />
brain from the damage caused by inhaled<br />
particulate matter. 1 As a component of cell<br />
membranes, the unsaturated fatty acids<br />
in breast milk, especially DHA, are important<br />
for healthy eye and brain development,<br />
particularly during the first two years of life.<br />
And as the body of scientific proof expands,<br />
so too do the regulatory requirements: DHA<br />
must now be present at a concentration of<br />
20–50 mg per 100 kcal in any infant formula<br />
that’s to be sold in the EU. 2<br />
smell). But, it’s not just sensory properties that make a good omega-3<br />
oil, purity is also crucial.<br />
The higher the proportion of unsaturated fatty acids in a raw oil,<br />
the more carefully it needs to be handled. On one hand, both the<br />
crude and refined oils must be protected and kept within a controlled<br />
atmosphere; on the other, it means that harsh refining environments<br />
need to be avoided. The chemical structures of omega-3 fatty acids<br />
contain several double bonds, which is why they react very quickly.<br />
For sources with extremely high omega-3 contents, such as tuna oil,<br />
which contains 25 % DHA, the oxidation potential is correspondingly<br />
high. It is too unstable to be refined in the same way that rapeseed or<br />
soy oil is, for example. At the same time, though, any contaminants<br />
that are harmful to health must be refined out to comply with food<br />
safety standards.<br />
Microalgae<br />
Many companies have now realised that microalgae can serve as a<br />
sustainable alternative raw material: they are relatively easy to cultivate<br />
and reproduce quickly (Fig. 1). For instance, the food industry<br />
considers them to be a productive marine source of omega-3. As<br />
they comprise up to 50 % fat, refining the raw oil is very efficient and,<br />
almost as importantly, they contain EPA and even more DHA than<br />
tuna oil. Fish does, too, but they get it from consuming algae — so<br />
why not start directly at the source? In addition, algae cultures are<br />
more environmentally friendly and protect fish stocks. Although the<br />
microalgae market is still in the discovery phase, growers and refiners<br />
such as Nutriswiss are already ahead of the curve and are driving<br />
further research and product development with algae oil.<br />
Sensory properties correlate with quality<br />
Optimising the sensory properties of omega-3 oils means more than<br />
just consumer acceptance; unpleasant off notes and a bad odour<br />
are symptoms of a decaying product. At Nutriswiss, a comprehen-<br />
High risk of oxidation<br />
Once the extracted oils are microencapsulated<br />
or powdered, the valuable fatty acids<br />
are completely isolated, which makes<br />
further decomposition reactions less likely.<br />
Most food operators understand that when<br />
handling oils containing polyunsaturated<br />
fatty acids, an oxidation reaction takes place<br />
when they come into contact with oxygen<br />
in the ambient air, which induces decomposition.<br />
The consequences clearly manifest<br />
themselves as off notes, an unappealing<br />
taste and a dark colour (mainly because of<br />
the formation of ketones and aldehydes that<br />
are responsible for that all-too-familiar fishy<br />
Fig.1: In the food and nutraceuticals industry, and beyond, microalgae are<br />
the new all-rounders. (Photo © : 123rf/Akhararat Wathanasing)<br />
No. 3 November/December <strong>2020</strong><br />
7
Oils and fats<br />
sive “key figure” profile is initially compiled for each oil in the factory’s<br />
own analytical laboratory. This determines how much “damage”<br />
has already occurred. Key factors such as the anisidine value, which<br />
measures the secondary degradation products of lipid-compound<br />
oxidation — such as aldehydes — provide information about the<br />
history of the raw material. After the refining process, the analyses<br />
are repeated: the removal of secondary oxidation products makes it<br />
possible to reduce the anisidine value in fish oil to less than 10 and,<br />
in some cases, less than 5, which corresponds to premium quality.<br />
Figures such as these are responsible for the company’s excellent<br />
reputation worldwide, especially as a supplier of high-purity oils and<br />
specialities for a wide range of sectors, including food, infant formula<br />
and pharmaceuticals.<br />
Contaminants<br />
Oxidation products are not the only compounds that have to be<br />
removed from a crude oil by refining. Owing to their apolar structure,<br />
lipids are especially susceptible to environmental contaminants.<br />
Oils from plants often accumulate the insecticides, fungicides and<br />
herbicides used in traditional cultivation. In addition, mineral oil saturated<br />
hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons<br />
(MOAH) – originating from exhaust gases or emissions from industrial<br />
facilities, among other sources – may have been transferred to the<br />
raw oil during processing and packaging. Marine animals are particularly<br />
at risk: other than cultivated (fermented) algae, which grow in<br />
tanks in a closed system, they are at risk of accumulating pesticides<br />
that might be present in the ocean.<br />
As with almost all sensitive natural raw materials, the challenge is<br />
implementing a gentle purification process that preserves the valuable<br />
polyunsaturated fatty acids. To remove certain contaminants,<br />
high temperatures are normally required, which actually promotes<br />
the formation of other contaminants (trans fatty acids and chlorinefatty<br />
acid esters such as 3-MCPD, for example). For 3-MCPD, in<br />
particular, more stringent regulations are due to come into effect in<br />
the EU for infant foods in January 2021. And, tighter restrictions are<br />
also being considered for other residues and applications.<br />
Choosing a gentle process<br />
Refining processes that work well for other vegetable oils operate at<br />
temperatures of 180–250 °C. As this would be an excessive thermal<br />
load for omega-3 oils, Nutriswiss has established a system to both<br />
maximise the yield and minimise the level of contaminants. At the<br />
centre of this technique is short path distillation (SPD), a particularly<br />
gentle physical separation process that is already well-established in<br />
the fish oil industry (Fig.2). Equipped with additional process technology,<br />
it is the procedure of choice for difficult-to-process raw materials,<br />
those that are heavily contaminated or when an extremely pure<br />
end product is required (baby food, for example). With the help of a<br />
finely controlled vacuum (with a pressure of less than 0.01 mbar) and<br />
short residence times, the thermal load on the product is significantly<br />
Fig. 2: The strength of short path distillation is that it is gentle on unsaturated<br />
fatty acids and yet provides effective purification. (Photo © : Nutriswiss)<br />
reduced, which minimises the formation<br />
of process contaminants. At the same<br />
time, free fatty acids, plasticisers and pesticides<br />
are removed to an extent that cannot<br />
be achieved with conventional technology.<br />
MOSH/MOAH levels can also be significantly<br />
reduced.<br />
Subsequently, the sensory quality can be<br />
further optimised by adding various absorbents<br />
– such as activated carbon – before the<br />
deodori sation stage. The final refining steps<br />
are only done directly before delivery to keep<br />
the storage times short and to prevent oxidation<br />
as far as possible. In the end, even volatile<br />
fish oils arrive with a completely neutral<br />
taste and odour, and look just like rapeseed<br />
oil with a light-yellow colouring.<br />
Welcome to the neutral zone<br />
Even though taste and quality are more<br />
closely linked to omega-3 oils than some<br />
other products, Nutriswiss insists on the<br />
very best conditions, right from the start.<br />
No matter whether the extract is derived<br />
from fish or algae or plants, the end result is<br />
sensorial neutrality. To facilitate this, carefully<br />
controlled and selected raw material sourcing<br />
is essential. As such, longstanding collaborations<br />
with suppliers and independent<br />
inspectors, coupled with the company’s own<br />
sealed food-grade containers, which protect<br />
the raw materials from contact with foreign<br />
materials and ambient oxygen, ensure the<br />
best possible outcome. In addition, before<br />
8 No. 3 November/December <strong>2020</strong>
Oils and fats<br />
production starts, each process and method is tested in the laboratory,<br />
so that all procedures and methods can be adapted to suit<br />
individual applications. To ensure that the key data and sensory<br />
profile information meet the requirements for pharmaceutical or<br />
special nutrition products, the refining steps are carefully planned<br />
and monitored. For instance, the composition of a baby food formulation,<br />
including the optimum ratio of omega-3 and omega-6, can be<br />
developed according to specific customer requirements. Afterwards,<br />
scale-up – from small quantities of around 500 kg batches of several<br />
tons – can be done, which can be particularly interesting when<br />
developing novel foods and other specialities. In fact, the process<br />
is so successful that when a member of the research team baked a<br />
Gugelhupf (yeast based) cake with fish oil instead of baking fat for his<br />
children, they didn’t notice any difference.<br />
References<br />
1<br />
Cheng Chen et al. (<strong>2020</strong>): Erythrocyte omega-3 index, ambient fine particles exposure and<br />
brain aging, Neurology Vol. 95 (8). https://n.neurology.org/content/95/8/e995. Accessed 9<br />
October <strong>2020</strong><br />
2<br />
Delegated Regulation (EU) 2016/127 of the Commission of 25 September 2015.<br />
https://eur-lex.europa.eu/eli/reg_del/2016/127/oj/deu. Accessed 14 October <strong>2020</strong><br />
Among others, Nutriswiss processes the following omega-3<br />
crude oils:<br />
Fish oil, Algae oil, Rapeseed oil/canola oil, Linseed oil, Hemp oil,<br />
Walnut oil, Chia oil, Perilla oil<br />
The refined or modified oil can then be delivered in:<br />
Bags-in-Boxes, Containers, Cartons and cups, Bottles, Barrels<br />
The omega-3 oils can be used in the following applications:<br />
Infant formula (powdered or spray-dried), any fortified foodstuff such<br />
as dairy products or soft drinks, Pharmaceuticals<br />
(encapsulated)<br />
For more information, please contact<br />
Frank Möllering<br />
Head of R&D, Nutriswiss AG,<br />
Industriering 30, CH-3250 Lyss<br />
Phone (central): +41 32 387 48 48<br />
info@nutriswiss.ch<br />
www.nutriswiss.ch<br />
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Rond-Point Georges Jolimaître - BP 259 - 81305 Graulhet Cedex - FRANCE<br />
Tel : + 33 (0)5 63 42 14 41 / welcome@weishardt.com<br />
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Functional sugars<br />
Photo © : Jennewein Biotechnologie<br />
Human milk oligosaccharides for health<br />
Dr. Bettina Gutiérrez<br />
Human milk oligosaccharides (HMOs) are functional sugars<br />
who have some important health benefits. The German<br />
company Jennewein Biotechnologie is producing these<br />
complex sugars in an industrial scale.<br />
Already at the end of the 19 th century, the Austrian paediatrician<br />
Theodor Escherich recognised that breastfed children had a<br />
7 times higher chance of survival than non-breastfed children. When<br />
researching the causes of this, human milk oligosaccharides (HMOs)<br />
were discovered in the breast milk. This means that it was discovered<br />
that these functional sugars, which are the third most significant<br />
components of breast milk after fats and lactose, are responsible for<br />
the well-being of infants. Later, in the '50s, '60s and '70s, scientists<br />
researched the characterisation of these HMOs, which are structurally<br />
diverse. There are around 200 types. In the '90s, their biologi cal<br />
and nutritional properties were researched. Scientific studies<br />
discovered that they have health benefits for both infants and adults.<br />
As an example, they protect against infections, are prebiotic, stabilise<br />
the immune system, prevent allergies and promote a healthy microbiome<br />
and the neuronal development.<br />
However, until recently, it was not possible to produce these<br />
HMOs in industrial scale to make them available to all. Jennewein<br />
Biotechnologie, a German company, took on this task: With the help<br />
of a self-developed fermentation process, they have succeeded in<br />
producing these sugar molecules on such a scale. This process is<br />
based on the bacteria strain E.coli BL21, which is genetically modified<br />
by the biotechnologists so that these bacteria produce the enzymes<br />
necessary to form HMOs. Since 2016 the most common oligosaccharide<br />
2’-fucosyllactose (2’-FL) has been supplied as a nutritional<br />
supplement to well-known baby food manufacturers in the USA, and<br />
since 2017 in Europe. For mothers who cannot breastfeed, this is a<br />
relief as their babies can now also benefit from the positive effects<br />
of breast milk. 2'-fucosyllactose is, like the other biotechnological<br />
produced HMOs chemically identical to its natural models in breast<br />
milk. It occurs in almost 80 % of all milk samples at a concentration<br />
of 3 g/l and has mainly the characteristics to ward off pathogens and<br />
promote a healthy gut microbiome.<br />
The product portfolio of the company includes, in addition to 2'-FL,<br />
amongst others the HMOs 3-fucosyllactose, lacto-N-tetraose, 3'-sialyllactose,<br />
6'-sialyllactose and the monosaccharides L-fucose and sialic<br />
acid (NANA). In addition to the specific benefits of these polysaccharides,<br />
they have an anti-adhesive effect in infants and adults, which<br />
means that they can prevent pathogens from entering the body cells<br />
of infants and adults. Most HMOs resemble the structure on the<br />
intestinal cells to which the pathogens bind. Due to this similarity,<br />
they can act as deceptive receptors by binding them to themselves,<br />
which prevents them from binding to the host cell, eliminating the<br />
pathogens from the intestine. This means they can inhibit an infection<br />
with viral and bacterial pathogens. As an example, 2'-fucosyllactose<br />
and 3-fucosyllactose protect against norovirus and rotavirus<br />
infections. Researchers from the company participated recently in a<br />
study entitled “Biotechnologically produced fucosylated oligosaccharides<br />
inhibit the binding of human noroviruses to their natural<br />
receptors” published in the well-known Journal of Biotechnology,<br />
10 No. 3 November/December <strong>2020</strong>
Functional sugars<br />
which is dedicated to this protective effect of<br />
HMOs. “Complex oligosaccharides such as<br />
HMOs can mimic the structure of the virus’<br />
natural receptor on human cells, coating<br />
the virus and preventing it from interacting<br />
with targets. We demonstrated this ability for<br />
2’-FL and 3-FL in our previous study in 2016.<br />
But the development of more complex oligosaccharides,<br />
which mimic the virus receptors<br />
even more closely, allows us to significantly<br />
improve this protective effect” states<br />
Dr. Katja Parschat, Co-Head of R&D at<br />
Jennewein Biotechnologie.”In this new study<br />
we included additional HMOs such as lacto-<br />
N-fucopentaose I and even more complex<br />
oligosaccharides” she adds.<br />
The company now wants to launch a new<br />
product generation with a 5'-HMO mix which<br />
comes even closer to the model of natural<br />
breast milk and consists of the five most<br />
common HMOs in natural concentrations:<br />
2'-fucosyllactose, 3-fucosyllactose, lacto-Ntetraose,<br />
3'-sialyllactose and 6'-sialyllactose.<br />
It is the first product to contain both neutral<br />
and acidic HMOs. In order to test whether<br />
this mix is well tolerated by infants and can<br />
guarantee the necessary safety requirements<br />
for approval in the EU, Jennewein<br />
Biotechnologie launched a clinical study<br />
in December 2018. This study was carried<br />
out in hospitals in Spain, Italy and Germany.<br />
324 babies divided into three groups were<br />
tested. The first interim results point to good<br />
tolerability of HMOs; the final results are<br />
expected at the end of this year.<br />
In addition to this mix, there are also other matters that point to a<br />
successful future and new market opportunities. In the future,<br />
further research on metabolic engineering and the microbiome<br />
will take place at the company’s new R&D centre in Bonn. The<br />
research work on the microbiome targets the development of products<br />
in the “healthy microbiomes” sector in baby and infant food.<br />
And in September of this year, the company was acquired by the<br />
Chr. Hansen Holding A/S, based in Hoersholm in Denmark.<br />
Chr. Hansen is a leading bioscience company that develops natural<br />
ingredients solutions for the food, nutritional, pharmaceutical and<br />
agricultural industries. The company produces cultures, enzymes,<br />
probiotics and natural colours for a variety of foods, confectionery,<br />
beverages, dietary supplements, animal feed and plant protection<br />
and has a profound experience in the fermentation technology. This<br />
means, that the strengths of Jennewein Biotechnologie and Chr.<br />
Hansen in the pre- and synbio tic market will be combined. And, that<br />
they will join their forces in a more and more growing global human<br />
milk oligosaccharides market.<br />
For more information, please contact<br />
Dr. Bettina Gutiérrez,<br />
press and public relations,<br />
Jennewein Biotechnologie,<br />
Part of Chr. Hansen Group<br />
bettina.gutierrez@jennewein-biotech.de
Nutrition and ageing<br />
Photo © : Adobe Stock/pressmaster<br />
Outstanding milk proteins & bioactives,<br />
allies of seniors<br />
Sandrine Tran & Elsa Trotier<br />
Introduction<br />
The global population is ageing rapidly as it is projected to double in<br />
30 years.<br />
Senior population projection to 2050 1<br />
Nowadays seniors actively seek to maintain<br />
good health in everyday life. Healthy ageing<br />
is the process of “developing and maintaining<br />
the functional ability that enables<br />
wellbeing in older age” 2 .<br />
Population<br />
Today<br />
929<br />
million<br />
+ 60<br />
years old<br />
Seniors have specific nutritional needs<br />
(proteins, calcium, etc.) as they are more<br />
exposed to health issues. Despite this, they<br />
do not want to feel categorized and nutritional<br />
products must be indulgent and attractive.<br />
The ageing population market<br />
2050<br />
2<br />
billion<br />
By 2050, WHO projects that 434 million people will be 80 or older<br />
Seniors can be defined as aged from 50 to<br />
65 according to countries (WHO, <strong>2020</strong>).<br />
Older population can be considered as the<br />
elderly. Two types of nutrition exist on the<br />
ageing population market: the senior nutrition<br />
and the geriatric nutrition.<br />
12 No. 3 November/December <strong>2020</strong>
Nutrition and ageing<br />
The senior nutrition<br />
The senior nutrition includes food supplements<br />
or functional food used as prevention<br />
to stay healthy and to prevent diseases<br />
among seniors and elderly people.<br />
It aims to accompany them to improve their well-being and prevent<br />
undernutrition. It is part of the clinical nutrition.<br />
The elderly’s protein and calcium needs<br />
It is mandatory to provide enough proteins to the body in order to<br />
increase the muscular protein synthesis.<br />
3, 4, 5<br />
Elderly people’s nutritional needs: recommended protein intake<br />
Elderly nutritional needs<br />
Adults<br />
Elderly<br />
Market data of the senior nutrition<br />
(Euromonitor, <strong>2020</strong>)<br />
Since 2017, the senior market has been<br />
expanding tremendously. During the<br />
past year, most launched senior-destined<br />
products were high protein milk and dietary<br />
supplements. They were mainly sold in<br />
China and 93 % of the launched products<br />
have a “senior (age 55+)” claim on<br />
packagings. In Europe, such claims are very<br />
few, as the population is less inclined to feel<br />
labeled (Mintel, <strong>2020</strong>).<br />
42 % of the senior nutrition products have<br />
more than 10 % of proteins and 14 % of<br />
them have a “high protein” claim (Mintel,<br />
<strong>2020</strong>).<br />
The geriatric nutrition<br />
The geriatric nutrition targets elderly people<br />
who have diseases or are undernourished.<br />
1st<br />
segment<br />
clinical<br />
nutrition<br />
H E L P T H R O U G H<br />
T H E I L L N E S S<br />
Geriatric<br />
nutrition<br />
market<br />
11.6<br />
USD<br />
billion<br />
Market data of the geriatric nutrition<br />
(Euromonitor, <strong>2020</strong>)<br />
Protein<br />
intake<br />
0.83g/kg/d<br />
A sufficient protein intake is necessary to maintain normal<br />
body functions<br />
* 1.2 times more than average adults<br />
** 1.6 times more than average adults<br />
In good health<br />
Protein<br />
intake<br />
1 - 1.2g/kg/d*<br />
Undernourished elderly people need a protein intake 50 % to 88 %<br />
superior to healthy adults but usually have low appetite. They also<br />
need a 1200 mg of calcium intake per day (EFSA, 2015; International<br />
Osteoporosis foundation).<br />
Seniors, prone to develop complications and<br />
diseases with age<br />
Undernourished<br />
Protein<br />
intake<br />
1.2 - 1.5g/kg/d**<br />
Undernutrition and sarcopenia<br />
One is undernourished if the BMI (Body Mass Index) is less than 21.<br />
It is recommended for an undernourished elderly person to avoid<br />
long fasting periods, such as night fasting (more than 12 hours a<br />
day), and to have a protein and energy enriched diet. 6<br />
Undernutrition is directly linked to muscle degradation. It aggravates<br />
sarcopenia, which is the reduction of muscular mass and physi cal<br />
abilities that eventually appear from 40 to 50. 7, 8 The leucine, an<br />
essential amino acid, is also important to trigger muscle synthesis<br />
9, 10<br />
with a necessary quantity of 2–-3 g among elderly people.<br />
To delay complications and avoid undernutrition when being older,<br />
prevention is recommended for seniors.<br />
Osteopenia<br />
After the age of 50, developing osteopenia (progressive bone weakening)<br />
is common. The aim is to strengthen bone mass to delay osteoporosis<br />
as much as possible. Osteoporosis corresponds to bone<br />
No. 3 November/December <strong>2020</strong><br />
13
Nutrition and ageing<br />
demineralization as the BMD (Bone mineralization density) lies 2.5<br />
points lower to standard values for young women. 11 Sarcopenia and<br />
osteopenia can both lead to mobility problems.<br />
+<br />
Proteins<br />
are needed<br />
for muscle<br />
synthesis<br />
Micellar Calcium highly bioavailable<br />
Prodiet ® Micellar caseins contain 2.6 % of<br />
highly bioavailable micellar calcium thanks<br />
to its dairy origin. “Slow” and “fast” proteins<br />
have a specific metabolism in postprandial<br />
conditions: 13,14<br />
Bone mass loss<br />
Bones become<br />
weaker<br />
(risk of fractures)<br />
Osteopenia<br />
Sarcopenia<br />
Muscle<br />
mass loss<br />
+<br />
Bones<br />
contain<br />
proteins<br />
Preventing sarcopenia and osteopenia among the elderly<br />
Other complications<br />
Indulgent and convenient nutritional products are important as loss of<br />
senses gradually increases like dysphagia and dysgeusia. Weakening<br />
of organ functions also lead to immune deficiencies and age is also<br />
one of the risk factors to develop type II diabetes. 12<br />
It is important to adapt seniors’ food with proper nutritional intakes,<br />
e. g. by consuming milk proteins. Besides, 56 % of seniors aged 60+<br />
declared that they consume dairy proteins as a source of protein<br />
intake (Euromonitor, <strong>2020</strong>).<br />
Ingredia’s proteins and bioactives as allies of seniors<br />
and the elderly<br />
For 70 years, the Group Prospérité Fermière – INGREDIA has<br />
specialized in dairy proteins and bioactives coming directly from its<br />
fresh milk collection.<br />
Micellar casein: a unique protein for senior and geriatric nutrition<br />
Micellar Caseins (92 % micellar caseins/8 % soluble proteins) are<br />
native proteins organized in micelles with a micellar calcium skeleton.<br />
The baseline depicts the continuously<br />
present amino acids in blood. Above means<br />
there is protein synthesis, below means<br />
avoiding protein breakdown is necessary.<br />
As they are slow proteins, micellar caseins<br />
can help to avoid muscle mass degradation<br />
and night fasting. Indeed, the amino acids<br />
are slowly released and can be digested up<br />
to 7 hours after ingestion. Oppositely, soluble<br />
proteins or whey proteins are fast proteins.<br />
Micellar caseins, an excellent<br />
amino acids profile<br />
Micellar caseins are particularly adapted<br />
for clinical nutrition. They have a higher<br />
chemi cal index* (146) compared to the<br />
FAO** protein reference (100).<br />
They are rich in all of the essential amino<br />
acids (EAA) (~43.5 %), in branched chain<br />
amino acids (BCAA) (~20.3 %) and in<br />
leucine (~9.2 %) for muscle synthesis.<br />
*Chemical index (CI): reveals the aptitude of<br />
the analysed protein to contain all the necessary<br />
amino acids.<br />
**FAO: Food and Agriculture Organization.<br />
Model of Caseins Micelle (Dalgleish, 2012)<br />
Prodiet ® Fluid, a micellar casein for highprotein<br />
beverages<br />
Prodiet ® Fluid is a micellar casein that<br />
contains more than 87 % of proteins on dry<br />
14 No. 3 November/December <strong>2020</strong>
Nutrition and ageing<br />
matter. It is the perfect solution to develop<br />
high protein beverages for seniors, as it<br />
provides a high content of leucine and an<br />
incredible fluidity up to 14 % of proteins,<br />
facilitating swallowing. The final product is<br />
stable for UHT and retort treatments, has a<br />
smooth texture and a delicious milky taste.<br />
For more information, please visit our<br />
website: https://www.prodiet-fluid.com/<br />
Protein hydrolysates, for faster absorption<br />
Protein hydrolysates are hydrolyzed peptides<br />
and amino acids that are faster absorbed by<br />
the organism, compared to intact proteins.<br />
Their amino acids are quickly available and<br />
have a great interest for clinical nutrition:<br />
they allow a quick activation of the peak of<br />
leucine, triggering muscle synthesis.<br />
Aminight, a beverage against overnight<br />
fasting with Prodiet ® Fluid and Prodiet ®<br />
Hydrolysate:<br />
Aminight is a high protein beverage with 12 % of proteins and 3.6 g<br />
of leucine. It limits elderly people’s overnight fasting, thanks to the<br />
combination of micellar caseins that reduce fasting periods, and whey<br />
protein hydrolysates for muscle synthesis thanks to the leucine peak.<br />
Bioactives, as nutritional protein solutions<br />
Osteum TM CPP, a calcium binding bioactive, to solidify bones<br />
Osteum TM CPP is a bioactive produced from native micellar caseins.<br />
It has a high calcium level that reaches more than 2 % and provides<br />
35 % of CPP (Casein phosphopeptides): they improve the calcium<br />
bioavailability and thus bone mineralization. Osteum TM CPP is an<br />
excellent ally to prevent osteopenia. Moreover, a study has shown<br />
that dairy CPP have a higher calcium binding capacity than the ones<br />
derived from acid precipitated caseins. 15<br />
Move up, a high protein milk drink to prevent sarcopenia<br />
and osteopenia<br />
Products aiming to prevent sarcopenia are fewer on the senior nutrition<br />
market than bone health products. Move up is an indulgent high<br />
protein milk drink for seniors, formulated to prevent sarcopenia and<br />
osteopenia. It contains both Prodiet ® Fluid and Osteum TM CPP, a very<br />
interesting combination as they have complementary functions for<br />
senior nutrition. It is rich in micellar calcium with 566 mg*/serving.<br />
*68 % of the Daily Recommended Intake of calcium.<br />
Your<br />
Magnesium<br />
all-rounder<br />
Magnesium Carbonate<br />
always fits<br />
◆ Various bulk densities available<br />
◆ DC grades for direct compression<br />
◆ Perfect for Magnesium fortification and as food additive<br />
◆ High Magnesium content ideal for muscle,<br />
nerve and bone concepts
Nutrition and ageing<br />
Proferrin ® , an outstanding immuno-modulator<br />
With age, seniors’ immune system efficacy naturally decreases.<br />
Proferrin ® is a natural lactoferrin coming from milk. It can be used<br />
for numerous benefits such as limiting infections, stimulating the<br />
immune system and enhancing gut health. 16<br />
Pep2dia ® , for delaying the onset of type II diabetes<br />
Pep2dia ® is a milk hydrolysate containing an active dipeptide, specifically<br />
designed for prediabetics. They have high blood sugar levels<br />
and risk to develop type II diabetes. Age, overweight, lack of physical<br />
activity are aggravating risks of developing diabetes 17 , and health<br />
conscious seniors can prevent it efficiently by combining good life<br />
hygiene and supplements such as Pep2dia ® .<br />
Conclusion<br />
The senior market keeps expanding, following the growing demand.<br />
Preventing seniors’ and the elderly’s health issues means maintaining<br />
their well-being longer.<br />
Micellar caseins are rich in calcium which limits osteopenia by<br />
increasing bone mineralization. With their high level in leucine, they<br />
can be used in products to prevent sarcopenia.<br />
Simultaneously, using a high-protein product<br />
with bioactives can become a real ally to<br />
healthy ageing. These ingredients are key for<br />
new senior products developments.<br />
Why choose milk protein<br />
High in<br />
essential<br />
Amino Acids*<br />
High<br />
nutritional<br />
quality<br />
Milky<br />
taste<br />
High in<br />
Leucine**<br />
reasons<br />
?6<br />
why<br />
High in<br />
micellar<br />
calcium<br />
Convenient<br />
for many<br />
applications***<br />
* Essential amino acids cannot be made by the body. As a result, they must come from food.<br />
** Necessary essential amino acid to trigger muscle synthesis (2-3g of Leucine)<br />
*** High protein drinks, pudding, yogurts, bars, shakes, finger foods...<br />
References<br />
1<br />
WHO, 2019.<br />
2<br />
WHO, <strong>2020</strong>.<br />
3<br />
ANSES, 2016. Saisine n° 2012-SA-0186 « Contribution des macronutriments à l’AET».<br />
4<br />
Bauer et al. 2013. Stratégie de prise en charge en cas de dénutrition protéino-énergétique chez la personne âgée, HAS, 2015. J Am Med Dir Asso<br />
5<br />
Réseau Espace Santé Cancer, 2015. Prise en charge du risque nutritionnel et de la dénutrition chez le patient atteint de cancer.<br />
6<br />
L’Assurance Maladie, 2015. Dénutrition chez la personne agée (> 70 ans) et aide à la prescription des Compléments Nutritionnels Oraux (CNO). Pp. 1-2.<br />
7<br />
Paddon-Jones D., Leidy H., 2014<br />
8<br />
Marzetti E., et al., 2017<br />
9<br />
Christos S. Katsanos et al., 2006<br />
10<br />
Hope Barkoukis, 2016<br />
11<br />
WHO, 2002. Proposed working definition of an older person in Africa for the MDS Project.<br />
12<br />
National Institute on Aging, 2019. Diabetes in older people.<br />
13<br />
Dangin, Boirie et al. 2001. The digestion rate of protein is an independant regulating factor of postprandial protein retention. Am J Physiol Endocrinol<br />
Metab.<br />
14<br />
Lacroix et al. 2006. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino<br />
acid requirement. Am J Clin Nutr.<br />
15<br />
T.Ono et al., 1998.<br />
16<br />
Zimecki M et al. 1999<br />
17<br />
Diabetes UK, 2019. Diabetes risk factors.<br />
For more information, please contact<br />
Elsa Trotier & Sandrine Tran,<br />
product managers Health and Nutrition<br />
e.trotier@ingredia.com<br />
s.tran@ingredia.com<br />
51 Av Lobbedez – CS 60946<br />
62033 Arras Cedex, France<br />
www.ingredia.com<br />
16 No. 3 November/December <strong>2020</strong>
Energy and endurance<br />
Photo ® : Stokkete/Shutterstock<br />
Be your best with<br />
Bioactive Collagen Peptides ®<br />
Innovative ingredients support collagenous “white tissue” and help athletes to get back<br />
to their performance levels after strain-related tendon issues<br />
Oliver Wolf<br />
Whether it’s skiing, running, ball games or<br />
even e-sports: All athletes need to deliver a<br />
consistently strong performance on a regular<br />
basis. Yet this means they often put their<br />
bodies under a lot of strain – which inevitably<br />
takes its toll physically. For instance,<br />
overused tendons are among the most<br />
common sports-related injuries suffered by<br />
athletes, be they amateur or professional. Yet<br />
there is a quick and easy way to help reduce<br />
the risk of such problems – supplementation<br />
with specific Bioactive Collagen Peptides ®<br />
TENDOFORTE ® from GELITA, which are<br />
proven to stimulate collagen-producing cells<br />
in tendons and ligaments.<br />
Product concepts with real benefits<br />
Collagen is the most abundant protein in the human body, making<br />
up 30 per cent of total protein content. It can be found in body parts<br />
such as bones, joints, ligaments, fascia or muscles – all of which<br />
are important for physically active people. There are a few reasons<br />
why collagen breakdown may outperform synthesis in sports, overuse<br />
being the main one. With its Bioactive Collagen Peptides ® , GELITA<br />
provides an optimal ingredient option for manufacturers who want to<br />
capitalise on the sports nutrition market, and create product concepts<br />
with real benefits for active consumers.<br />
To understand why collagen supplementation is so vital – especially<br />
for athletes – it’s important to look at the relationship between<br />
so-called white tissue and muscles. The whole musculoskeletal<br />
No. 3 November/December <strong>2020</strong><br />
17
Energy and endurance<br />
system is connected and protected by a network of connective tissue,<br />
comprising muscle fascia, tendons, ligaments, cartilage, bone and<br />
skin. Collectively known as “white tissue”, this network is formed<br />
mainly by collagen. Yet most people don’t think about white tissue<br />
until it becomes stressed and strained. This can result in back pain,<br />
Achilles tendon pain, ankle sprains, plantar fasciitis, patella tendon<br />
pain and ACL (anterior cruciate ligament) tears or IT band (iliotibial<br />
band) issues – like aching, burning, or tenderness on the outside of<br />
the knee. The white tissue supports the whole muscular system, it<br />
has an equally high rate of tissue turnover, and its own amino acid<br />
needs. Collagen is the main component of white tissue, and supplementation<br />
with Bioactive Collagen Peptides ® attends to the specific<br />
needs of the white tissues that are highly recruited in physical activity,<br />
giving structure to the whole body and supporting physical mobility.<br />
Improving muscle functions<br />
Muscles are made primarily of contractile material – otherwise known<br />
as “red tissue”. Therefore, it’s perhaps no surprise that most of the<br />
existing science and nutrition solutions – and manufacturers of<br />
sports nutrition – have so far focused on the contractile properties of<br />
muscles. But now, there are new scientific insights on muscles and<br />
their functions.<br />
Muscles are different from many other tissues in the way that their<br />
contractile fibres are enclosed in layers of collagen-rich white tissue<br />
– called the muscle fascia – a skin-like casing that influences muscle<br />
function. The fascia facilitates muscle contraction, which then<br />
engages the joint, including tendons and ligaments, ensuring the<br />
mechanical forces between muscles and bones create optimal movement<br />
(Millward and Smith, 2019). What this means? Muscles are so<br />
much more than “red tissue”. They are a remarkably effective combination<br />
of red contractile material with the white tissue network, as well<br />
as blood vessels and nerves – a fusion that strongly contributes to<br />
muscle function, growth and performance (Gillies and Lieber, 2011).<br />
“Almost every activity-related injury and its manifestations, such as pain,<br />
are to some extent linked to the white tissue, as well as an injured athlete’s<br />
ability to quickly return to play.” Photo ® : adimas/Fotolia<br />
The white tissue plays many other roles in<br />
muscle health and performance too. It bears<br />
most of the muscle load, so that a person’s<br />
range of motion primarily reflects their white<br />
tissue properties. Also, nearly every activityrelated<br />
injury and its manifestations, such as<br />
pain, are to some extent linked to the white<br />
tissue, as well as an injured athlete’s ability to<br />
quickly return to play.<br />
Scientifically proven<br />
Many manufacturers in the sports nutrition<br />
field are actively seeking ingredient options<br />
to create products for consumers who want<br />
to tackle sports-related injuries, or enhance<br />
their overall performance. GELITA, the<br />
leading manufacturer of collagen peptides,<br />
has created scientifically proven specific<br />
Bioactive Collagen Peptides ® that optimally<br />
stimulate white tissue cells to produce new<br />
collagen matrix proteins. This helps athletes<br />
train at high intensity, while remaining injuryfree.<br />
A speedier return to training<br />
Regular intake of collagen peptides can help<br />
boost collagen production and, in sports<br />
nutrition, to reduce activity-induced tendon<br />
problems is a real need state. Research has<br />
shown that the specific Bioactive Collagen<br />
Peptides ® found in TENDOFORTE ® stimulate<br />
the RNA expression and biosynthesis<br />
of collagen, proteoglycans and elastin in<br />
Achilles tendons. This was proven by an<br />
Australian study that found subjects with<br />
long-term symptoms of chronic Achilles<br />
tendinopathy were able to return to running<br />
within three months when supplementing<br />
their diet with TENDOFORTE ® , and were<br />
able to keep running for the remainder of the<br />
trial period. Research has also demonstrated<br />
that oral ingestion of the specific collagen<br />
peptides improves the extension properties<br />
of finger joints.<br />
In Germany, researchers at the University<br />
of Freiburg Department of Sport examined<br />
the role of TENDOFORTE ® in reducing ankle<br />
sprains and improving ankle stability. They<br />
concluded that six months’ supplementation<br />
with TENDOFORTE ® resulted in significant<br />
18 No. 3 November/December <strong>2020</strong>
Energy and endurance<br />
improvements in ankle stability, reduced<br />
sprains and a reduced risk of further injury in<br />
the three-month follow-up period, suggesting<br />
that its effects are long-term (Dressler et al.,<br />
2018).<br />
So, by taking TENDOFORTE ® , athletes<br />
can avoid strain-related tendon issues. In<br />
addition, these specific peptides can help<br />
athletes make a quicker return to training, at<br />
previous performance levels.<br />
Consumer appeal<br />
The ability of Bioactive Collagen Peptides ® to<br />
deliver a targeted health benefit is linked to<br />
the profile of peptides in the product, characterized<br />
by specific molecular weight distribution.<br />
The Bioactive Collagen Peptides ®<br />
can deliver benefits at a relatively low daily<br />
dose, which is crucial for successful finished<br />
product applications, formulation efficiency<br />
and consumer acceptance. Ultimately,<br />
the GELITA range of Bioactive Collagen<br />
Peptides ® enables a variety of finished<br />
product concepts, supported by productspecific<br />
science.<br />
As well as TENDOFORTE ® , the GELITA Bioactive<br />
Collagen Peptides ® portfolio also includes<br />
FORTIGEL ® , which is proven to stimulate joint<br />
cartilage regeneration; FORTIBONE ® which<br />
contributes to bone health by promoting the<br />
biosynthesis of the extracellular bone matrix,<br />
and BODYBALANCE ® , which improves<br />
body toning by helping to increase muscle<br />
mass while reducing body fat. With targeted<br />
marketing, these innovative ingredients<br />
can contribute to exciting new sports nutrition<br />
products that will appeal to the growing<br />
numbers of consumers with a keen interest<br />
in this market.<br />
For more information, please contact<br />
Oliver Wolf<br />
Head of B2B Marketing (Global)<br />
Global Marketing & Communication<br />
GELITA AG<br />
Uferstr. 7, 69412 Eberbach, Germany<br />
www.GELITA.com<br />
No. 3 November/December <strong>2020</strong><br />
19
Minerals<br />
Photo ® : Adobe Stock/nd3000<br />
Magnesium Carbonate – Oldie but Goldie<br />
Physiology and requirements<br />
Without the vitally important element Magnesium, it is impossible for<br />
living cells to fulfill their manifold physiological functions. Magnesium<br />
is of central importance in almost all metabolic processes and essential<br />
for the neuromuscular and cardiovascular system. A sufficient<br />
supply of Magnesium is important throughout lifetime – especially<br />
during pregnancy, childhood and old age. People in these phases<br />
of life and people with certain diseases have an increased need for<br />
Magnesium.<br />
The fortification of foods with Magnesium Carbonate or the use of food<br />
supplements can prevent a deficiency. With a Magnesium content of<br />
approx. 25 %, Magnesium Carbonate is an ideal source of Magnesium.<br />
It can be a good option for the prevention and therapy of a<br />
variety of different diseases. In Europe, the Nutrient Reference Value<br />
(NRV) for the daily intake of Magnesium is<br />
375 mg/d for adults. It is advantageous to<br />
have a continuous supply with Magnesium<br />
throughout the day.<br />
Magnesium Carbonate is an inorganic<br />
Magnesium Salt and is also known as the<br />
Magnesium Salt of carbonic acid. The natural<br />
form of Magnesium Carbonate (magnesite/<br />
bitter spar/magnesia alba) is beside Dolomite<br />
the most important Magnesium mineral on<br />
earth.<br />
Described and mostly naturally occurring<br />
forms of Magnesium Carbonate are, among<br />
others:<br />
Variations Chemical Formula Assay<br />
Magnesite MgCO 3<br />
28.8 % Mg, 71.2 % Carbonate<br />
Barringtonite MgCO 3<br />
*2H 2<br />
O 20.9 % Mg, 51.6 % Carbonate, 27.5 % Water<br />
Nesquehonite MgCO 3<br />
*3H 2<br />
O 18.4 % Mg, 45.4 % Carbonate, 36.3 % Water<br />
Lansfordite MgCO 3<br />
*5H 2<br />
O 14.8 % Mg, 36.5 % Carbonate, 48.7 % Water<br />
Artinit Mg 5<br />
(OH) 2<br />
(CO 3<br />
) 4<br />
*3H 2<br />
O 27.5 % Mg, 54.4 % Carbonate, 18.1 % Water/Hydroxide<br />
Hydromagnesite Mg 5<br />
(OH) 2<br />
(CO 3<br />
) 4<br />
*4H 2<br />
O 26.6 % Mg, 52.5 % Carbonate, 21.0 % Water/Hydroxide<br />
Dypingite/Giorgiosite Mg 5<br />
(OH) 2<br />
(CO 3<br />
) 4<br />
*5H 2<br />
O 25.7 % Mg, 50.7 % Carbonate, 23.7 % Water/Hydroxide<br />
Prokovskite Mg 2<br />
CO 3<br />
(OH) 2<br />
34.6 % Mg, 42.7 % Carbonate, 22.8 % Hydroxide<br />
20 No. 3 November/December <strong>2020</strong>
Minerals<br />
Dr. Paul Lohmann ® produces a highpurity<br />
and extremely versatile Magnesium<br />
Carbonate for miscellaneous applications. It<br />
meets the purity requirements of Ph. Eur.,<br />
USP, FCC and E 504 and offers an excellent<br />
stability. Customized requirements can be<br />
taken into account during production, as well.<br />
purity and nutritional value. Dr. Paul Lohmann ® has developed qualities<br />
that meet extra low heavy metal limits. Of course, our Magnesium<br />
Carbonate is also Kosher/Halal.<br />
The high quality standards and the focus on approval in pharmaceutical<br />
applications have proven their worth: Dr. Paul Lohmann ® was<br />
one of the first manufacturers of Magnesium Carbonate to receive the<br />
General properties and documentation<br />
Name:<br />
Magnesium Hydroxide Carbonate; Magnesium Carbonate, basic<br />
Formula:<br />
approx. 4MgCO 3<br />
*Mg(OH) 2<br />
*5H 2<br />
O<br />
Molecular weight:<br />
approx. 485 g/mol<br />
Appearance:<br />
white powder<br />
Odor:<br />
neutral<br />
Flavor:<br />
sandy, neutral<br />
Solubility (20 °C):<br />
< 1 g in 100 ml water<br />
pH (1% Suspension): approx. 10 (basic)<br />
Assay Magnesium (Mg): approx. 25 %<br />
Monographs of the European and American<br />
Pharmacopoeias (Ph. Eur., USP) describe<br />
Magnesium Carbonate as a basic Magnesium<br />
Carbonate containing crystalline water,<br />
which contains a certain amount of alkaline<br />
earth oxide, calculated as Magnesium Oxide.<br />
The Ph. Eur. also distinguishes a light and a<br />
heavy quality of Magnesium Carbonate. It is<br />
a white powder or granules.<br />
The bioavailable Magnesium Salt is almost<br />
insoluble in water but easily soluble in<br />
combination with acids, releasing CO 2<br />
. In<br />
contrast to soluble Magnesium Salts, an up<br />
to five times lower amount of the Mineral<br />
Salt is needed to obtain the same amount of<br />
Magnesium in the final product. This minimizes<br />
costs and enables various positioning<br />
possibilities in the field of food supplements,<br />
at the same time.<br />
Magnesium Carbonate is a fine white powder<br />
and available in different types. Depending<br />
on the application, an extra light (approx.<br />
65 g/l) or extra heavy quality (500 g/l) can<br />
be used. As granules, it is ideal for direct<br />
compression to tablets.<br />
In the GMP and DIN EN ISO certified production<br />
facilities, Magnesium Carbonates are<br />
produced which meet the highest possible<br />
quality criteria in terms of product safety,<br />
certificate of suitability (CEP/CoS) for its product as an active pharmaceutical<br />
ingredient (API) according to the European Pharmacopoeia<br />
from the European Directorate for the Quality of Medicines (EDQM).<br />
For the submission of pharmaceuticals to the health authorities, a<br />
detailed documentation of the active ingredient is required. In order<br />
to simplify this for customers, Dr. Paul Lohmann ® provides the corresponding<br />
CEPs (Certificate of Suitability to the European Pharmacopeia)<br />
for both light and heavy quality.<br />
Manufacturing<br />
Seventy percent of the world’s supply of Magnesium raw material is<br />
mined and processed in China. However, due to its sustainable orientation<br />
and extremely high purity requirements, Dr. Paul Lohmann ®<br />
has always used sources from European regions. Partnerships with<br />
mining companies, responsible mining and an active recultivation<br />
and renaturation program are the focus of attention.<br />
Environmental protection and the certainty to process raw materials<br />
of the highest quality requirements, allow us to guarantee that<br />
Magnesium Carbonates with the highest quality are produced in a<br />
unique synthesis process.<br />
In a special manufacturing process, different grades of Magnesium<br />
Carbonate are produced at the two production sites in northern<br />
Germany under strict safety and quality requirements. This is a<br />
continu ous process with maximum precision. The Magnesium<br />
Carbonate basic ensures the highest purity in the final product.<br />
By varying the manufacturing conditions, products with very different<br />
bulk densities can be obtained, and the purity of the individual<br />
No. 3 November/December <strong>2020</strong><br />
21
Minerals<br />
Health Claims<br />
Magnesium contributes to maintenance of important body functions:<br />
– Normal teeth and bones<br />
– Reduction of fatigue/tiredness<br />
– Normal muscle function<br />
– Functioning nervous system<br />
– Normal mental function<br />
– Energy metabolism<br />
– Protein synthesis<br />
– Normal electrolyte balance<br />
qualities is adjusted during the manufacturing process. In addition,<br />
customized services can be offered at the end of the manufacturing<br />
process. Directly compressible granules with different binding<br />
agents are examples of this. Due to their special properties, Dr. Paul<br />
Lohmann ® Magnesium Carbonates are in demand worldwide.<br />
Advantages of Dr. Paul Lohmann ® Magnesium Carbonate:<br />
– Known and constant Magnesium content, as defined<br />
– Constant composition<br />
– Controlled purity (absence of other elements)<br />
– Consistent, application-optimized density<br />
(filling volume/bulk density)<br />
– Reliable structure (grain size, morphology)<br />
– Assured solubility (e. g. effervescent tablets)<br />
– Uniform crystal structure<br />
Application areas<br />
Photo ® : Fotolia/alfa27<br />
With its high Magnesium content of about 25 %, Magnesium<br />
Carbonate is an extremely versatile product. Magnesium Carbonate<br />
is generally approved in the EU for food fortification and for the use<br />
in food supplements.<br />
Magnesium Carbonate is classically used to supplement Magnesium<br />
ions in e. g. effervescent tablets. Due to the multitude of physiologi cal<br />
functions that Magnesium performs in the body, manufacturers<br />
of food and food supplements have the opportunity to market the<br />
Magnesium Carbonate contained therein with correspondingly effective<br />
health claims. This becomes possible if the minimum requirements<br />
for a Magnesium source are met in accordance with the<br />
claim for the final product listed in the Annex to Regulation (EC) <br />
No 1924/2006.<br />
Magnesium Carbonate is harmless to health and therefore has no<br />
maximum level restriction as food additive E 504. As an acidity<br />
regulator, separating agent or filler, it is approved for all foods that<br />
may contain additives. This includes organic products as well. For<br />
example, it can show its pH-value stabilizing function in beverages<br />
and serve as a filler in tablet production.<br />
In the pharmaceutical sector, Magnesium Carbonate is used in pharmaceuticals<br />
for the regulation of gastric acidity (antacids), as a mild<br />
laxative or as a phosphate binder for the treatment of hyperphosphatemia.<br />
Due to its unique properties, Magnesium Carbonate is not only valued<br />
as a raw material in the pharmaceutical and food industries. It also<br />
shows technical advantages in the sports sector. Here Magnesium<br />
Carbonate is also sold under the names magnesia or chalk. It is used<br />
by apparatus gymnasts, strength athletes and climbers to absorb the<br />
sweat produced by their hands and thus increase the grip of their<br />
hands and the sliding ability on the apparatus spars. It can also be<br />
used in thermal insulation materials and as a filler in plastics, paper,<br />
paints and rubber, as well as in cosmetics in powder form.<br />
For more information, please contact<br />
Dr. Paul Lohmann GmbH & Co. KGaA<br />
Hauptstr. 2<br />
31860 Emmerthal, Germany<br />
sales@lohmann4minerals.com<br />
www.lohmann4minerals.com<br />
References<br />
1<br />
Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims<br />
made on foods, other than those referring to the reduction of disease risk and to children’s<br />
development and health<br />
2<br />
Regulation (EC) No 1924/2006 or the European Parliament and of the Council on nutrition<br />
and health claims made on foods<br />
22 No. 3 November/December <strong>2020</strong>
Women‘s health<br />
Photo ® : Shutterstock/ESB Professional<br />
Her ally for a healthy intimate flora<br />
A convenient orally administered probiotic shown to support women’s intimate health<br />
Elodie Aragon and Marilou Luneau<br />
Probiotics for women’s health<br />
Over the past five years, the market for nutritional<br />
ingredients for women’s health carried<br />
on evolving to a more mature market, driven<br />
by consumers’ interest and research and<br />
development. With robust scientific backing<br />
and product development on the rise, global<br />
probiotic markets have been, in fact, growing<br />
fast for more than a decade. Lumina Intelligence<br />
confirms products have diversified<br />
from initial cores of gastro-intestinal health<br />
and immunity to a much broader range of<br />
benefits including skin, sports performance,<br />
brain health and more female-focused areas<br />
like vaginal health, urinary tract infections<br />
(UTIs), pregnancy and osteoporosis. Probiotics<br />
research and development is undeniably<br />
popular, with over 1600 ongoing human<br />
clini cal trials on probiotics listed in clinicaltrial.gov<br />
and WHO’s trial database.<br />
According to Grand View Research, the women’s health and beauty<br />
supplement market has reached $49.8 Billion in 2019 and the estimated<br />
compound annual growth rate (CAGR) for <strong>2020</strong> –2026 is<br />
4.75 %. The probiotics for women’s health core growth areas are:<br />
vaginal health, urinary tract infections, pregnancy and skin health.<br />
Among non-supplement women users, 40 % of them think their<br />
«feminine health issues» could be improved by using supplements.<br />
Probiotics for women’s health is a fast-growing market, increasingly<br />
attracting women through online and on-site retail places. Although<br />
women’s probiotic market used to be a niche market, it is now<br />
becoming a strong differentiation factor for product development,<br />
explaining why, since the past two years, a lot of new probiotic<br />
products target women, and consequently consumers online engagement<br />
is increasing: between December 2017 and January <strong>2020</strong> the<br />
number of reviews for women’s intimate health probiotics increased<br />
by 804 %, on average from the 20 countries studied. Specific probiotics<br />
are gaining attraction as they are a natural alternative to the<br />
conventional over-the-counter solutions for vaginal health. Women<br />
are willing to try them out especially when vaginal health conditions<br />
are recurrent, which alters general quality of life.<br />
No. 3 November/December <strong>2020</strong><br />
23
Women‘s health<br />
Probiotics for women’s health is a major opportunity to expand brand<br />
portfolios with a potential target audience of over 1.4 billion women.<br />
Genito-urinary issues, including vulvovaginal candidiasis, urinary<br />
tract infections and bacterial vaginosis are the leading conditions,<br />
bringing women to seek out medical advices, prescriptive drugs and<br />
to investigate natural efficient complementary supplements, such as<br />
probiotics.<br />
Lactobacilli: The gatekeepers of feminine health<br />
The female vaginal microflora is a rich and complex ecosystem,<br />
mainly consisting of Lactobacilli which support the vaginal environment<br />
and health. During her lifespan, every woman encounters<br />
specific health and well-being issues according to her lifestyle,<br />
physio logy, hormonal cycles and life stages. Vaginal balance is<br />
which incapacitates commensal bacteria.<br />
Candida albicans are also often found in the<br />
gastrointestinal tract, as part of a commensal<br />
bacteria. Candida can co-exist normally<br />
in the vagina without any problem, and a<br />
proper Candida albicans balance is an indicator<br />
of healthy vaginal microbiota. However,<br />
it may cause trouble if it outnumbers other<br />
microorganisms. Three out of four women<br />
will have an imbalance with a Candida albicans<br />
prominent microflora at some point in<br />
their life.<br />
How do probiotics promote vaginal<br />
health, even during times of occasional<br />
bacterial imbalance<br />
Lactobacilli can help rebalance the vaginal<br />
microflora and promote vaginal comfort<br />
during times of occasional vaginal imbalance.<br />
Lactobacilli probiotics, which have<br />
a positive effect on endogenous microflora<br />
could thus help support the vaginal microflora<br />
and protect against some undesirable<br />
bacteria.<br />
fragile, and many internal or external factors can affect this balance:<br />
gut health, immunity, mood balance, oral health, intimate health...<br />
they all have been linked by scientists to endogenous microbiota.<br />
Acting upon the gut or vaginal microbiota, specific probiotics can<br />
help each individual woman at every stage of her life, from puberty to<br />
menopause. The benefits of probiotics to support women’s health are<br />
increasingly recognised, mainly due to their ability to maintain and<br />
restore digestive and vaginal microflora balance, with positive consequences<br />
on feminine health as well as on digestive health, occasional<br />
stress or natural defenses. As per most of the beneficial effects of<br />
probio tics, the benefits on intimate health are not homogeneous for<br />
all the probio tics but are strain specific.<br />
What is the difference between bacterial vaginosis and<br />
vaginal yeast infection?<br />
Bacterial vaginosis<br />
is defined as a vaginal dysbiosis characterized by a decrease in<br />
concentration of Lactobacilli in the vagina and an increase in concentration<br />
of anaerobic bacteria such as Gardnerella vaginalis, Atopobium<br />
vaginae, Mycoplasma hominis, Prevotella, Porphyromonas. It<br />
is the most common vaginal infection in women of childbearing age.<br />
Vaginal yeast infection<br />
is also due to an imbalance in the vaginal flora. In this condition,<br />
the problem is a fungus called Candida, such as Candida albicans,<br />
24 No. 3 November/December <strong>2020</strong>
Women‘s health<br />
Meet women’s new best friend:<br />
ROSELLA<br />
To recolonize the vaginal microflora zone,<br />
choosing the right bacteria strain is crucial.<br />
Moreover, only a handful of probiotic supplements<br />
taken orally can do the trick. L. plantarum<br />
P17630 (Proge 17630 ® ), ROSELLA,<br />
is one of them.<br />
L. plantarum P17630 (Proge 17630 ® ),<br />
ROSELLA is a unique strain isolated from a<br />
healthy vaginal flora with full mechanistic and<br />
clinical evidence of efficacy on a wide spectrum<br />
of benefits, from helping to maintain<br />
proper vaginal balance, including from oral<br />
intake, to being used for recurrent Vulvovaginal<br />
Candidiasis (rVVC). This probio tic strain<br />
is one of the most documented in the world<br />
in the women’s health area, as it has been<br />
studied in over 800 women, in six clini cal<br />
studies, including two by oral intake. In<br />
combination or not with conventional treatments<br />
for candidiasis (anti-fungal) women<br />
saw an improvement in candidiasis with a decrease in symptoms<br />
including less swelling, redness, burning or itching infection that can<br />
be caused by an overgrowth of bad bacteria. This probiotic strain also<br />
helped reduce the risk of recurrence of this candidiasis*.<br />
ROSELLA is scientifically backed by mecha nistic data. Studies<br />
showed this specific strain was able to adhere and interfere with C.<br />
albicans (in vitro studies). It demonstrated vaginal colonization and<br />
persistence following oral intake (validated efficacy dose: 5B CFU/<br />
day).<br />
ROSELLA restores flora diversity associated with a healthy vaginal<br />
flora and promotes vaginal diversity associated with a healthy vaginal<br />
microbiota by normalizing pH. Furthermore, there are clinical<br />
evidences that this unique strain helps promote continued vaginal<br />
health in Vulvovaginal Candidiasis and in recurrent Vulvovaginal<br />
Candidiasis as adjunctive treatment with triazole or alone.<br />
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Women‘s health<br />
How can oral probiotics, after passage through the gut,<br />
have a beneficial impact on the vaginal microflora?<br />
Probiotics taken orally will pass through the gut, colonize the intestine<br />
and will be excreted in faeces. Anatomically, anus and vagina are<br />
very close, so naturally bacteria will pass and arrive in vagina in order<br />
to colonize it. This natural phenomenon occurs with “bad” bacteria<br />
causing infections like bacterial vaginosis, but also with “good”<br />
bacteria like probiotics. Gut to vagina passage was confirmed by clinical<br />
studies, in particular with ROSELLA which is found in vagina after<br />
oral intake. In Montella study, ROSELLA also showed persistence as<br />
ROSELLA was not only found in vagina after oral intake, but also after<br />
a 15 days wash-out period.<br />
Colonization of the vaginal microflora and persistence<br />
study in healthy women [Montella, 2013 and 2014]<br />
On 24 healthy women with a normal vaginal flora, an optimal oral<br />
intake dose was determined of 5B CFU/day with two cycles of 15<br />
days intake followed by 15 days washout among different dose and<br />
regimen. ROSELLA strain was identified by Polymerase Chain Reaction<br />
(PCR) with specific strain primers in both faecal and vaginal<br />
samples, even after a 15 days washout period, demonstrating the gut<br />
to vagina passage, colonization and persistence.<br />
Efficacy study in healthy women prone to experiencing<br />
temporary imbalances in their vaginal microflora<br />
[Vladareanu, 2018]<br />
Following the Montella pilot study<br />
confirming dose and safety, an efficacy<br />
study was conducted on 93 healthy women<br />
with recurrent vulvovaginal candidiasis<br />
enrolled during relapse-free period. These<br />
women took either ROSELLA (5B CFU/<br />
day) or a placebo during three cycles of 15<br />
days, followed by 15 days washout. At T0,<br />
around 60 % of women have an abnormal<br />
vaginal flora (LBG IIa to LBG III). In the<br />
ROSELLA group, there was a significant<br />
increase (p
Women‘s health<br />
[Nava 2002, results]<br />
In 2014, De Seta study results on pH normalization,<br />
increase of lactobacilli and improvement<br />
of symptoms, ROSELLA’S legiti macy<br />
was equally confirmed.<br />
In 2016, Cianci, in order to open indications,<br />
ROSELLA was tested in a pilot study<br />
on 94 women with bacterial vaginosis (BV)<br />
and aerobic vaginitis (AV). After 15 days, a<br />
signifi cant increase of reported clinical resolution<br />
was observed.<br />
Why maintaining vaginal pH balance is essential to<br />
keeping a healthy vaginal flora?<br />
The pH scale runs from 0 to 14. A pH of less than 7 is considered<br />
acidic, and a pH of more than 7 is basic. A normal vaginal pH level<br />
is between 3.8 and 4.5, which is moderately acidic. However, what<br />
constitutes a “normal” pH level can vary slightly during a women’s life<br />
due to internal changes, and many external factors can also modify the<br />
pH levels in this delicate zone. Whilst an acidic vaginal environment is<br />
protective and creates a barrier that prevents unhealthy bacteria and<br />
yeast from multiplying too quickly and causing infection, weak acid,<br />
or raised pH levels provides the perfect setting for unhealthy bacteria<br />
to develop, hence putting women at risk of contracting various more<br />
or less severe infections.<br />
For more information, please contact<br />
Lallemand Health Solutions<br />
HealthSolutions@Lallemand.com<br />
https://lallemand-healthsolutions.com/en/rosella/<br />
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No. 3 November/December <strong>2020</strong><br />
27
Clinical trials<br />
Photo ® : Adobe Stock/Robert Wilson<br />
Adaptive designs in clinical trials:<br />
when, why and how?<br />
The use of dietary supplements and nutraceuticals has been<br />
constantly growing among people who are looking for ways to promote<br />
wellbeing and health. Additionally, their demand for clarity around the<br />
attributes on product labeling is on the rise. Particularly, they want<br />
to know that the products they are ingesting are safe and effective<br />
based on rigorous clinical evidence obtained from studies testing the<br />
same products. This shift of consumers’ attitude highlights the importance<br />
of well-designed and well-conducted clinical trials in building<br />
and growing market of the products. A clinical trial can be conducted<br />
to assess absorption/bioavailability active ingredients, safety or tolerance,<br />
and/or efficacy of product, as well as consumers’ acceptance<br />
and satisfaction of product. All information and clinical results gathered<br />
in clinical trials serve as a foundation for marketing and scientific<br />
communications, as well as regulatory requirements.<br />
Biofortis a CRO (Contract Research Organization) that is part of<br />
Mérieux NutriSciences, specializes in clinical services for nutraceutical<br />
and food products and has successfully completed over 250<br />
trials since 2002. Biofortis provides all expertise required for clinical<br />
study, ranging from scientific insights to fieldwork and data valorization<br />
needed to successfully manage international multicentric studies<br />
to assess bioavailability, efficacy, safety/tolerance.<br />
A team of scientists, statisticians and methodologists, focuses on<br />
each clients’ unique expectations and needs, and works to adapt<br />
persona lized, customized and robust designs. Traditionally, clini cal<br />
trials are run in three phases: design, execution, and data analysis.<br />
An alternative approach is the Adaptive<br />
Design trial which can be used to optimize<br />
the scientific data delivery and decrease cost<br />
and time to market, while still using robust<br />
and specific statistics models. The adaptive<br />
designs can be applied across all phases<br />
of clinical research, from early-phase dose<br />
response and safety designs to confirmatory<br />
trials.<br />
We interviewed two Biofortis experts; Hélène<br />
Chevallier (Clinical Methodologist) and<br />
Florence Gillaizeau (Senior Biostatistician),<br />
on the basics of adaptive design and why<br />
you could consider this for your future study<br />
with Biofortis.<br />
What is an adaptive design clinical trial?<br />
There is no universal definition of an adaptive<br />
design. As compared to traditional design<br />
trials, where you design, then you conduct<br />
the study, and finally you analyze the results,<br />
adaptive design is more flexible in that it<br />
allows the data to drive modifications of the<br />
original design (if scientifically justified and<br />
necessary) prior to the formal completion<br />
of the study. This clinical study design uses<br />
28 No. 3 November/December <strong>2020</strong>
Clinical trials<br />
accumulating data to decide how to modify<br />
certain aspects of the study without undermining<br />
the validity and integrity of the trial.<br />
After almost ten years since the first draft,<br />
the Food and Drug Administration (FDA)<br />
finally edited the final version of the “Adaptive<br />
Designs for Clinical Trials of Drugs and<br />
Biologics Guidance for Industry” last year<br />
(FDA, November 2019). In this guidance,<br />
the following definition is used: “an adaptive<br />
design is defined as a clinical trial design<br />
that allows for prospectively planned modifications<br />
to one or more aspects of the<br />
design based on accumulating data from<br />
subjects in the trial”.<br />
There are some main concepts common<br />
to all the references that discuss adaptive<br />
designs. First, during the study, every single<br />
modification needs to be prospectively<br />
planned into the protocol. After reviewing<br />
results of data analysis, usually through an<br />
interim analysis, with full control of the type I<br />
error (which means the control of the risk of<br />
a false positive conclusion), some modifications<br />
including but not limited to, changes<br />
to the sample size and population or premature<br />
discontinuation of one study arm, can<br />
be implemented. According to the FDA guidance,<br />
the interim analysis is defined as “any<br />
examination of data obtained from subjects<br />
in a trial while that trial is ongoing”. The<br />
analysis can be done in a fully blinded procedure<br />
or unblinded procedure.<br />
Could you explain more specifically the<br />
interim analyses?<br />
According to the International Council for<br />
Harmonisation of Technical Requirements<br />
for Pharmaceuticals for Human Use (ICH),<br />
involving regulatory members (e. g. the European<br />
Commission, the US FDA, the Ministry<br />
of Health, Labour and Welfare of Japan)<br />
and industry Members (e. g. the Pharmaceutical<br />
Research and Manufacturers of<br />
America), an interim analysis is any analysis<br />
intended to compare treatment arms<br />
with respect to efficacy or safety at any time<br />
prior to the formal completion of a trial. The<br />
results are prepared by an independent statistician<br />
(other than the study statistician)<br />
and reported to an independent Data Monitoring<br />
Committee (DMC) that recommends to the sponsor whether<br />
to continue, modify or stop the trial. The DMC members must have<br />
no financial or intellectual conflicts of interests in the outcome of the<br />
study. Therefore, the participation of employees of the sponsor in this<br />
committee is discouraged. DMCs typically include clinicians and at<br />
least one biostatistician with expertise in clinical trial and interim data<br />
analysis.<br />
To avoid introducing bias into ensuing study design, conduct or interpretation,<br />
all interim analyses are carefully planned and described in<br />
the protocol and it is strongly recommended to maintain interim analysis<br />
blind for investigators, sponsors or anyone outside DMCs.<br />
Are there different kinds of adaptive design?<br />
There are several types of adaptive designs and more than one can<br />
be applied to the same trial. Below is a summary of the most common<br />
types.<br />
Fig. 1 : Different types of adaptive designs<br />
Adaptive designs are applicable to both early and confirmatory clinical<br />
trials. Adaptive designs for early clinical trials such as the Continual<br />
Reassessment Method (CRM) and seamless designs deal mainly<br />
with establishing safe and effective doses or dose–response relationships.<br />
The CRM aims to identify the dose with optimal efficacy/<br />
response and is more accurate in estimating the maximum tolerable<br />
dose compared to a conventional design. Meanwhile, a seamless<br />
adaptive design combines two phases traditionally carried out in<br />
separate trials into one single study.<br />
Based on the review of interim results, change(s) to a study can<br />
occur in different development phases. For example, an adaptive<br />
randomization design involves shifting study participant allocation<br />
ratio towards more promising or informative treatment(s); an enrichment<br />
or subgroup design allows for adjustments to the recruitment<br />
of a specific subgroups based on efficacy endpoint; a group sequential<br />
design may lead to the premature termination of a trial based<br />
on efficacy, safety, and futility endpoints; adaptive-hypotheses design<br />
allows for changes in hypotheses, study endpoints and/or statistical<br />
No. 3 November/December <strong>2020</strong><br />
29
Clinical trials<br />
methods; and the sample size reassessment permits sample size<br />
adjustments to achieve a desired power.<br />
According to a review of Bothwell and colleagues (2018) which<br />
reviewed 142 adaptive design clinical trials published between 1978<br />
and 2014, the most popular adaptive designs used are the seamless<br />
designs (mainly combining phase II and III; i.e., Seamless IIb/III),<br />
followed by the group sequential design, and finally the enrichment<br />
or subgroups design.<br />
Could you describe the three most popular adaptive designs, highlighting<br />
the advantages and challenges?<br />
Seamless design II/III<br />
Fig. 2: Seamless phase II/III adaptive design, also called “drop the losers or<br />
pick the winners design”<br />
The seamless phase II/III design is one of the most famous adaptive<br />
designs, also called “drop the losers or pick the winners design”.<br />
This design addresses the early (phase II) and confirmatory (Phase<br />
III) objectives, which are traditionally investigated in separated trials,<br />
in one trial. As shown in figure 2, during the first interim analysis, the<br />
Group C (the “loser”) is not judged effective enough (according to a<br />
previous efficacy threshold clearly defined in the protocol). Similarly,<br />
Group A (the “loser”) is dropped during the second interim analysis.<br />
This leads to a final phase with only two groups, the Group B (the<br />
“winner”) and placebo. All the patients included in Group B during<br />
the entire trial are included in the final data analysis for efficacy<br />
assessment. The advantage of this adaptive design is that there is<br />
no stop between the two phases, and doses are selected or stopped<br />
during all the trial according to interim results.<br />
The seamless design is a popular adaptive design because it allows<br />
testing of a larger number of doses with a smaller number of patients<br />
at the beginning of the trial. In the middle of the trial, more patients<br />
can be allocated to the more superior dose because the inferior<br />
ones were stopped before the end of the trial. This design is usually<br />
approved by the authorities for important and innovative therapeutic<br />
treatments. It should be noted that at the end of the first stage,<br />
meaning the first interim analyses, the lack of statistical power may<br />
increase the risk of concluding inefficiency of test products. Indeed,<br />
the efficacy threshold needs to be prospectively planned and it can<br />
be difficult to define it at the time of the protocol development. There<br />
is also an extensive logistics requirement as sponsors needs to adapt<br />
quickly the products production, and formulations and galenic forms<br />
tested in the trial need to be the definitive ones. Finally, because the<br />
primary outcome has to be assessed during the interim analyses,<br />
this design is not applicable if the primary outcome can only be<br />
assessed at the later stage of trials.<br />
Group sequential design<br />
The group sequential design allows for prematurely stopping a trial<br />
due to safety, efficacy (if the treatment is very promising) or futility<br />
(if the treatment is not efficient) with the options of additional types<br />
of adaptations (as seen above) based on interim results. This design<br />
is advantageous in that it can help reduce cost and time as well as<br />
minimize the risk of study participants if the test product appears<br />
unsafe. However, it can be challenging to pre-define the safety, efficacy,<br />
and futility limits for prematurely stopping the trial.<br />
Sample size readjustment<br />
Usually, the sample size is prospectively determined using a targeted<br />
treatment effect size, an assumption about the variability of the<br />
primary endpoint, the desired Type I error rate, and the statistical<br />
power. Inaccurate estimates of the parameters lead to an underpowered<br />
or overpowered study, both of which have negative consequences.<br />
Sample size re-estimation designs allow the parameter<br />
estimates to be updated during an ongoing trial, which can then be<br />
used to adjust the sample size. In theory, the sample size re-estimation<br />
can lead to an increase or a decrease in sample size, though in<br />
practice this is done only to increase the sample size. One reason<br />
is that trials often have other objectives in addition to their primary<br />
objective, including safety objectives for which there is a need of<br />
a certain amount of exposure data. Another reason is for practical<br />
consideration when the recruitment can be completed by the time of<br />
sample size re-estimation, particularly when the primary endpoint is<br />
disease outcomes and observed late in trials. Finally, the potential to<br />
decrease the sample size is best achieved through a group sequential<br />
design with an opportunity to decrease the study sample size by<br />
early termination at the time of the interim analysis.<br />
Blinded methods for sample size adjustment should generally be<br />
considered for most studies. They are based on nuisance parameters<br />
such as variance. Examining the data in this blinded analysis<br />
does not introduce statistical bias, thereby no statistical adjustments<br />
are required. In contrast, sample size adjustment based on knowledge<br />
of the unblinded treatment-effect sizes at an interim stage of<br />
the study can cause an increase in the Type I error rate that can<br />
increase risk of a false positive conclusion. To protect against such<br />
an increase, a statistical adjustment of theType I error rate is necessary<br />
for the final study analysis.<br />
What is your opinion about conducting adaptive design?<br />
Do you think it’s a real opportunity for industry?<br />
Adaptive designs have become popular due to the promise of<br />
greater flexibility and efficiency. When adaptive designs are used<br />
properly, advantages include a smaller sample size, a more efficient<br />
treatment development process (seamless or enrichment designs),<br />
30 No. 3 November/December <strong>2020</strong>
and an increased likelihood of correctly<br />
answering the clinical question of<br />
interest. Thus, it is a real opportunity for<br />
industry to save time and money. Additionally,<br />
a key benefit of adaptive designs<br />
is the ability to reduce the number of<br />
patients exposed to unnecessary risk<br />
with an inefficient treatment. However,<br />
there are some constraints, depending<br />
on the type of adaptive designs, such as<br />
the possible need of independent DMC,<br />
the increase of products logistic, and<br />
statistical concerns.<br />
Are there some regulatory challenges?<br />
Are the authorities supportive of this<br />
kind of design?<br />
While some ethics committees can<br />
be reluctant to authorize some adaptive<br />
designs, such as seamless designs<br />
with a lack of feedback between<br />
phases, regulatory agencies as the FDA<br />
or the European Medicines Agency<br />
(EMA) are promoting the use of adaptive<br />
designs. As an example, among<br />
the 142 studies reviewed by Bothwell<br />
et al., 9 % and 12 % were used for FDA<br />
and EMA product approval considerations,<br />
respectively. Additionally, adaptive<br />
designs are accepted by the European<br />
Food Safety Authority (EFSA) for health<br />
claims submission. If the design is built<br />
with strong scientific justifications and<br />
sound ethical practices and is technically<br />
feasible, there is no reason for the project<br />
to be rejected.<br />
Conclusion<br />
The use of adaptive design is still limited<br />
even in pharma/drug studies. Regulatory<br />
agencies are familiar with adaptive<br />
designs but it is still used by only a<br />
few sponsors. At first, as it was new, it<br />
was used more for innovative treatments<br />
which had to be developed very quickly<br />
because no solution was available for the<br />
patient. So, it was more used for heavy<br />
therapeutics. Now, it is becoming more<br />
and more popular so we can reasonably<br />
think that it will also be considered in the<br />
field of nutrition and food!<br />
References<br />
Guidance for Industry published by the FDA in November 2019 (Adaptive Design Clinical Trials for Drugs and<br />
Biologics).<br />
Several publications that can help with recommendations for reporting, or systematic reviews with examples:<br />
Adaptive Designs in Clinical Trials: Why Use Them, and How to Run and Report Them. BMC Med. 2018 Feb 28;16(1):29.<br />
doi: 10.1186/s12916-018-1017-7<br />
Bothwell LE, Avorn J, Khan NF, et alAdaptive design clinical trials: a review of the literature and ClinicalTrials.govBMJ<br />
Open 2018;8:e018320. doi: 10.1136/bmjopen-2017-018320.<br />
Cerqueira, F. P., Jesus, A. M. C., & Cotrim, M. D. (2019). Adaptive Design: A Review of the Technical, Statistical, and<br />
Regulatory Aspects of Implementation in a Clinical Trial. Therapeutic Innovation & Regulatory Science. https://doi.<br />
org/10.1177/2168479019831240<br />
Flight L, Arshad F, Barnsley R, et al. A Review of Clinical Trials With an Adaptive Design and Health Economic<br />
Analysis. Value Health. 2019;22(4):391-398. doi:10.1016/j.jval.2018.11.008<br />
For more information, please contact<br />
Biofortis Mérieux NutriSciences - Europe<br />
3, route de la Chatterie<br />
44800 Saint Herblain, France<br />
Phone +33 (0)2 40 20 57 99<br />
biofortis-contact@mxns.com<br />
biofortis.merieuxnutrisciences.com<br />
Biofortis Research – US<br />
800-A South Rohlwing Road<br />
Addison, IL 60101<br />
Phone (630) 617-2000<br />
biofortisresearch@mxns.com<br />
www.biofortisresearch.com<br />
No. 3 November/December <strong>2020</strong>
Fortified dairy alternatives<br />
Mineral fortification in dairy alternatives<br />
Dr. Sabrina Fischer and Miriam Feja<br />
Introduction<br />
Dairy products are considered healthy because they provide the<br />
body with minerals and vitamins. Fermented milk products such as<br />
yoghurt are excellent sources of protein, calcium, phosphorus, riboflavin,<br />
thiamine, vitamin B12, folate, niacin, magnesium and zinc.<br />
They also have a positive image because the probiotics they contain<br />
have a beneficial effect on the immune system, as demonstrated by<br />
various studies. 1<br />
Nevertheless, an increasing number of people cannot or do not<br />
want to consume milk products. The reasons range from ecological<br />
and animal welfare concerns, to health aspects such as cow’s milk<br />
allergies, lactose intolerance, concerns around calorie intake and<br />
preventing high cholesterol. 2,3 Plant-based alternatives are therefore<br />
becoming increasingly important, and producers are facing the challenge<br />
of developing products that are as close as possible to cow’s<br />
milk in terms of taste, appearance, stability and nutritional value.<br />
Plant-based milk alternatives<br />
and yoghurts<br />
Plant-based milk alternatives are liquids that<br />
consist of plant proteins homogenised in<br />
water, often together with emulsifiers, stabilisers,<br />
oil, sugar, salt and flavours to imitate<br />
the appearance and consistency of cow’s<br />
milk. 2 Soy is still the most commonly used<br />
source of protein for plant-based drinks and<br />
yoghurts, followed by coconut, almonds and<br />
oats. In recent years, a large number of new<br />
plant-based sources of protein have entered<br />
the market, such as nuts (cashews, hazelnuts<br />
and walnuts), rice, peas, lupine and hemp.<br />
These sources of protein differ widely in terms<br />
of nutritional value, mineral profile and amino<br />
acid profile – as well as in terms of taste.<br />
32 No. 3 November/December <strong>2020</strong>
Fortified dairy alternatives<br />
Indeed, some plant-based raw materials<br />
give rise to unpleasant taste profiles (e. g.<br />
bitter, green or beany notes), and therefore<br />
present a major challenge for manufacturers<br />
looking to produce a pleasanttasting<br />
product. Plant-based yoghurts can<br />
be produced in the same way as traditional<br />
yoghurts, employing fermentation with lactic<br />
acid-producing bacteria such as Bifidobacterium<br />
and Lactobacillus. 3 It may also be<br />
necessary to add sugars for the fermentation<br />
process, depending on the raw material<br />
used. The advantage of this process is<br />
that non-dairy yoghurts also contain living<br />
cultures. However, they still lack the vitamins<br />
and the minerals, especially calcium, found<br />
in cow’s milk-based products. 4<br />
Mineral fortification and<br />
health claims<br />
While calcium enrichment of soy drink has<br />
become relatively common, enrichment<br />
with other minerals and vitamins is still rare.<br />
Added minerals in plant-based yoghurts<br />
are also uncommon, even though fortification<br />
offers an additional opportunity for<br />
promoting health benefits. Minerals such as<br />
calcium, magnesium, potassium and zinc in<br />
particular allow many health claims besides<br />
bone health, addressing topics such as<br />
immunity, muscle function or energy (in line<br />
with the rules on health claims under Regulation<br />
(EC) No 1924/2006).<br />
Table 1: Overview of common mineral salts approved for fortification in Europe. 5<br />
Organic salts are marked in bold, and salts offered by Jungbunzlauer are marked in blue.<br />
that organic mineral salts have higher bioavailability than inorganic<br />
ones. 6–8 Jungbunzlauer offers a wide range of organic mineral salts<br />
in different granulation grades. These are suitable for fortification of<br />
various food matrices and are well established in the dairy industry.<br />
Calcium is important for healthy bones<br />
Calcium is one of the most important modifiable dietary factors for<br />
normal bone development and maintaining bone mass in old age.<br />
About 99 % of the calcium contained in the human body is stored<br />
in the bones in the form of calcium hydroxyapatite. The amount of<br />
calcium present influences peak bone mass. 9 Multiple studies have<br />
shown that insufficient calcium intake is associated with an increased<br />
risk of osteoporosis and related fractures. 9–11 As well as calcium,<br />
other minerals such as magnesium, zinc and vitamin D are crucial<br />
for healthy bones. 6 However, there are still many people whose<br />
calcium intake is inadequate. The USDA Advisory Committee’s <strong>2020</strong><br />
scientific report states that 44 % of Americans are at risk of calcium<br />
inadequacy. 12<br />
Solubility and bioavailability of<br />
different mineral salts<br />
The addition of minerals to complex food<br />
matrices is often challenging and the right<br />
choice of mineral salts is crucial to success.<br />
Mineral salts can be broadly divided into<br />
soluble and insoluble salts. Whereas soluble<br />
salts have an influence on pH and taste,<br />
insoluble salts can lead to a sandy mouthfeel<br />
and sedimentation.<br />
Mineral salts can also be divided into organic<br />
and inorganic salts. Organic mineral salts are<br />
salts of naturally occurring acids, such as<br />
citric acid or lactic acid. They usually have<br />
a more neutral taste than inorganic mineral<br />
salts. In addition, various studies indicate<br />
No. 3 November/December <strong>2020</strong><br />
33
Fortified dairy alternatives<br />
Dairy products are the most important source of calcium in our diet<br />
and provide 52–65 % of daily calcium requirements. 10,13 Milk contains<br />
120 mg calcium per 100 ml, whereas most plant-based alternatives<br />
contain significantly less. Soy drinks, for instance, contains only<br />
25 mg calcium per 100 ml and coconut drink contains 0 mg per<br />
100 ml. 14,15 Other minerals, such as magnesium and zinc, are only<br />
present in small quantities in many dairy alternatives. People who<br />
do not consume milk-based products typically have a lower intake<br />
of these minerals and are therefore at a higher risk of inadequacy. 11<br />
Enrichment of milk alternatives can therefore make an important<br />
contribution to a healthy diet.<br />
Challenges in the production of fortified dairy alternatives<br />
When enriching milk alternatives, it’s very important to consider the<br />
various properties of the mineral salts in question. Soluble calcium<br />
salts in particular, such as calcium lactate or calcium chloride, can<br />
lead to interactions with proteins due to the high concentration of<br />
free calcium ions. This can affect the pH value and stability of the<br />
product when it is heat treated. Insoluble inorganic salts such as<br />
calcium carbonate or calcium phosphate do not have this problem,<br />
but can precipitate or cause a sandy mouthfeel. Tricalcium citrate is<br />
a good compromise. It has a solubility of approx. 1 g/l and exhibits<br />
inverse solubility: solubility decreases as temperature increases, so<br />
only a very low concentration of free calcium ions is present during<br />
the heat treatment process. 16 Jungbunzlauer offers tricalcium citrate<br />
in a micronised grade (M1098: min. 98 % < 10 μm). Due to the very<br />
fine particle size, sedimentation is less pronounced and the product<br />
offers a pleasant mouthfeel, since the particles are too small to be<br />
detected on the tongue.<br />
Magnesium salts are less common in fortifying dairy alternatives.<br />
During processing, their behaviour is similar to that of calcium salts,<br />
but less mineral salt is required because the recommended daily<br />
intake for magnesium is lower than for calcium. 5 As a result, magnesium<br />
salts have less severe negative impacts on the product than<br />
calcium salts. Among the neutral-tasting magnesium salts, trimagnesium<br />
citrate offers the highest mineral content, but the insoluble<br />
inorganic salt magnesium phosphate has been used more often<br />
because of its neutral taste and low price. However, consumers are<br />
becoming increasingly sceptical about phosphate-containing ingredients.<br />
Various studies have indicated that excessive consumption of<br />
phosphates from food additives can be associated with health risks.<br />
The EFSA therefore called for an upper limit on phosphate levels in a<br />
new risk assessment in 2019. 17<br />
Fortifying with minerals, masking unpleasant flavours<br />
Unpleasant off-tastes can be a problem, especially with plant-based<br />
products: plant proteins can have a beany, green or bitter taste,<br />
making the product less attractive for the consumer.<br />
Previous trials have shown that mineral salts of organic acids – such<br />
as citrate or gluconate salts of magnesium, sodium or potassium –<br />
can mask bitterness and other unpleasant flavours. 18 Fortification<br />
with mineral salts can therefore improve not only the mineral content<br />
but also the taste of milk alternatives. The effect of each mineral salt<br />
on the flavour can vary depending on the matrix and the source of<br />
plant protein used: the mineral salt with the largest impact on offnotes<br />
in the flavour of one product may have much less effect in<br />
another.<br />
Before examining the taste-masking properties of mineral salts, it is<br />
essential to identify the dominant taste characteristics of the various<br />
plant materials. To cover as wide a range of off-notes as possible, a<br />
soy drink and a walnut drink were selected as basis drinks to which<br />
mineral salts were added.<br />
Screening for off-notes<br />
The first step involved a benchmark soy drink (consisting of only water<br />
and 9 % soy) and a self-prepared walnut drink (5 % nut content; for<br />
recipe see table 2) being screened by an internal sensory panel.<br />
These screenings were carried out in form of a CATA (‘check all that<br />
apply’) test. CATA is a rapid descriptive method in which the panellists<br />
are given a list of attributes and are asked to determine which attributes,<br />
as perceived by the panellists, are most relevant to the samples.<br />
Quantitative results were then produced by counting the frequency<br />
of each attribute for each sample. The aim of these sessions was to<br />
find the most relevant attribute for subsequent discrimination tests.<br />
The panellists identified the beany notes in the soy drink and the<br />
bitter notes in the walnut drink as the most dominant off-notes.<br />
Following these screenings, paired comparison tests were carried out<br />
to analyse the soy drink and the walnut drink, focusing on the two<br />
attributes identified by the panellists. As well as the paired comparison<br />
test, the panellists were asked to identify their preference and to<br />
comment on their impression of the taste. This additional information<br />
did not form part of a representative consumer test.<br />
34 No. 3 November/December <strong>2020</strong>
Fortified dairy alternatives<br />
Minerals for masking unpleasant flavours<br />
in milk alternatives<br />
Experimental setup<br />
For each comparison test of the soy drink, the panellists were given<br />
a plain soy drink sample and a sample containing 0.15% added<br />
mineral salt (sodium gluconate, trimagnesium citrate, tripotassium<br />
citrate, calcium lactate gluconate or potassium lactate). The panellists<br />
were asked to identify which sample they perceived as more<br />
beany.<br />
The same test setup was also used to evaluate the taste-masking<br />
properties of mineral salts in walnut drinks. Here, the panellists were<br />
asked to identify which sample they perceived as more bitter.<br />
The test was carried out as a blind experiment; all samples were<br />
randomised and identified only by three-digit codes. The soy drink<br />
was commercially available and was used both with and without<br />
added mineral salts. The walnut test matrix was prepared and fortified<br />
with one of the mineral salts afterwards.<br />
Table 3: Sensory evaluation of soy drink – comments by panellists<br />
Walnut drink results<br />
The addition of 0.15 % sodium gluconate, trimagnesium citrate,<br />
calcium lactate gluconate and potassium lactate significantly<br />
reduced the bitter off-note of the walnut drink (n = 20, α = 0.05).<br />
The panellists also preferred these samples over the plain walnut<br />
drink.<br />
Table 4: Sensory evaluation of walnut drink – comments by panellists<br />
Conclusion<br />
The sensory tests conducted showed that minerals are not only<br />
valuable for mineral fortification of milk substitutes but may also<br />
be suitable for masking undesired off-tastes. The results also<br />
indicated how crucial the selection of the right mineral salt is for<br />
masking specific off-notes.<br />
Table 2: Recipe for walnut drink<br />
The first step in preparing the walnut drink involved mixing the stabilisers<br />
with a quarter of the required amount of water. Another quarter<br />
of the water was heated to 60° C and mixed with lecithin. Both solutions<br />
were stirred thoroughly for 30 minutes. The walnut paste was<br />
meanwhile soaked at 60° C in the rest of the water.<br />
This mixture was then transferred to a Becomix ® and reheated to<br />
60° C. The lecithin solution was homogenised, and then the lecithin<br />
solution and the stabiliser solution were stirred into the walnut-water<br />
mixture. The resulting mixture was homogenised at 60° C and then<br />
had its pH adjusted to 7.0. Finally, the product was pasteurised.<br />
Soy drink results<br />
The addition of 0.15% sodium gluconate, trimagnesium citrate or<br />
tripotassium citrate significantly reduced the beany off-note in the<br />
soy drink (n = 20, α = 0.05).<br />
The samples containing sodium gluconate and trimagnesium citrate<br />
were preferred over the plain soy drink.<br />
While 0.15 % tripotassium citrate worked well for masking beany<br />
off-notes of the soy drink, calcium lactate gluconate and potassium<br />
lactate worked well for the bitter off-note of the walnut drink.<br />
Sodium gluconate and trimagnesium citrate masked both off-notes.<br />
At a concentration of 0.15 %, trimagnesium citrate fulfils a dual<br />
function: its addition allows the product to be claimed as a source<br />
of magnesium, and it also helps enhance the taste of the product<br />
by masking beany and bitter off-notes.<br />
Mineral fortification in non-dairy yoghurt<br />
As described above, specific minerals can be utilised as taste<br />
masking agents for undesired off-notes in soy and walnut drinks.<br />
While milk alternatives are often fortified so that their mineral<br />
content matches that of cow’s milk, fortification of non-dairy yoghurt<br />
can go further. Yoghurt products are generally considered healthy<br />
and their set portion size allows them to be used as an important<br />
source of minerals. Therefore yoghurt fortification can be used to<br />
achieve “high in minerals” status – an especially interesting option<br />
for vegan yoghurts.<br />
However, since non-dairy yoghurts are produced directly from milk<br />
alternatives, additional minerals could have a negative effect on the<br />
stability, texture and taste of plant-based yoghurts. The following trials<br />
No. 3 November/December <strong>2020</strong><br />
35
Fortified dairy alternatives<br />
therefore focused on the influence of minerals on taste and texture in<br />
a plant-based yoghurt matrix. Unlike the trials with non dairy drinks<br />
not only one mineral was added, these used a combination of trimagnesium<br />
citrate and tricalcium citrate at concentrations that allow a<br />
“high mineral content” claim. Because soy is still the most common<br />
basis for non-dairy yoghurt, the following trials were carried out using<br />
a soy-based matrix.<br />
The US Food and Drug Administration (FDA) gives a daily recommended<br />
intake of 1300 mg calcium and 420 mg magnesium per<br />
day. A product can be labelled as “high in calcium/magnesium” if it<br />
provides a minimum of 20 % of the daily value (DV) (FDA 21CFR).<br />
The reference amount customarily consumed (RACC) is set at 150 g<br />
per portion, as this is a typical amount for commercially available<br />
single-portion yoghurts.<br />
In the EU, Regulation (EU) No 1169/2011 requires that 100 g of final<br />
product contains 30 % of the Nutrient Reference Value (NRV) if the<br />
product is to be labelled as “high in calcium/magnesium”. The NRV<br />
is set at 800 mg calcium and 375 mg magnesium per day.<br />
Table 6: Recipe for soy yoghurt<br />
To produce the test yoghurts, a soy drink (protein content approx.<br />
5–7 g per 100 g) was added to 0.1% pectin and heated to 90° C<br />
for 5 minutes in a Thermomix ® . Trimagnesium citrate and tricalcium<br />
citrate were then stirred in until evenly suspended. After cooling the<br />
mixtures to below 40° C, the yoghurts were inoculated with lactic<br />
acid bacteria. The yoghurts were then poured into sealable cups and<br />
placed in a warming chamber at 40° C until a final pH of 4.7 was<br />
achieved.<br />
Table 5: Overview of requirements for “high in calcium/magnesium”<br />
claims in EU and USA<br />
In the experimental setup, the quantities for a “high in calcium/<br />
magnesium” claim under US regulations were used. Besides visually<br />
analysing stability, the internal sensory panel also tested the influence<br />
of the added minerals on the flavour of the product.<br />
Experimental setup<br />
Apart from the raw materials and the use of starter cultures for dairy<br />
alternatives, dairy and non-dairy yoghurt are processed in exactly the<br />
same way.<br />
Table 7: Nutritional values of the test yoghurt (values are per 150 g yoghurt)<br />
Sensory evaluation of mineral-fortified soy yoghurt<br />
Triangle tests (α = 0.05) were used to find out if the addition of large<br />
quantities of tricalcium citrate and trimagnesium citrate influences<br />
the overall taste of a fortified product compared to the non-fortified<br />
product.<br />
In a triangle test, panellists are given three samples, two of which are<br />
identical, and are asked to identify the third, non-identical sample. A<br />
significant difference between this sample and the other two samples<br />
would show that mineral fortification affects the flavour of the product.<br />
The panellists were also asked to comment on their decision and to<br />
choose their preferred yoghurt for each test set.<br />
The test was carried out as a blind experiment; all samples were<br />
presented in a randomised order and identified only by threedigit<br />
codes.<br />
36 No. 3 November/December <strong>2020</strong>
Fortified dairy alternatives<br />
Sensory results and conclusion<br />
The sensory panel (n = 18) could not detect<br />
any difference between the fortified and the<br />
unfortified versions of the soy yoghurt.<br />
It can therefore be concluded that the addition<br />
of mineral salts has no impact on the<br />
taste, texture, stability or appearance of the<br />
product.<br />
The results demonstrate that a fortification<br />
with trimagnesium citrate and tricalcium<br />
citrate has no detectable effect on taste or<br />
texture for the consumer, even if large quantities<br />
of these minerals are used.<br />
avoid this, it is crucial that soluble mineral<br />
salts are added after the heating step. Since<br />
heat treatment is carried out to sterilise the<br />
product, the mineral salts must be added<br />
using a sterile method. There are various<br />
options:<br />
– Mixing the minerals with water to produce<br />
a slurry or solution, followed by heat treatment<br />
before adding the minerals to the<br />
drink or yoghurt<br />
– Adding the mineral salt solution using<br />
sterile filtration<br />
– Adding the mineral salts to the fruit preparation,<br />
then sterilising this preparation<br />
before adding it to the yoghurt<br />
Insoluble mineral salts present a lower risk<br />
of affecting product stability, so they can<br />
usually be added in micronised powder form<br />
before the heating step. Soluble mineral salts<br />
with low or moderate solubility can only be<br />
Cleaner label – replacing calcium<br />
phosphate<br />
As mentioned above, mineral salts of phosphates<br />
are still commonly used, even though<br />
EFSA has issued new advice on phosphates.<br />
17<br />
Bioactive Collagen Peptides ® stimulate<br />
the body’s own collagen metabolism<br />
To further investigate whether phosphates<br />
could be replaced with clean label ingredients<br />
in non-dairy yoghurt, another soy<br />
yoghurt test was conducted. A soy yoghurt<br />
fortified with calcium phosphate was<br />
compared to a version fortified with tricalcium<br />
citrate in a triangle test.<br />
Again, the panellists (n = 12) could not detect<br />
any difference between the two versions.<br />
This indicates that cleaner labelling by<br />
switching from phosphates to label-friendly<br />
citrates can easily be achieved without any<br />
negative impact on the taste, texture, colour<br />
or appearance of the final product.<br />
Body Toning<br />
• Increases lean mass and<br />
decreases fat mass<br />
Bone Health<br />
• Increases bone<br />
mineral density<br />
Osteoporosis<br />
Normal bone<br />
matrix<br />
Beauty from Within<br />
• Increases skin elasticity<br />
and reduces depth<br />
of wrinkles<br />
Connective Tissue<br />
Improvement<br />
• Strengthens ligaments<br />
and tendons<br />
Both of these mineral salts have very low<br />
solubility and comparable reactivity. This<br />
means that citrates could be integrated into<br />
the production of non-dairy yoghurt without<br />
any change to the production process.<br />
Joint Health<br />
• Recovers joint cartilage<br />
and reduces joint pain<br />
Incorporating mineral salts into the<br />
production process<br />
As mentioned above, products containing<br />
dissolved cations such as calcium tend<br />
to be unstable during heat treatment. To<br />
GELITA AG · Uferstr. 7 · 69412 Eberbach · Germany · www.gelita.com
Fortified dairy alternatives<br />
instead of a soy-based one to find out whether stability can be maintained<br />
if a different plant protein is used. Provided that the yoghurt is<br />
processed as recommended, it was found that these versions did not<br />
demonstrate a lack of stability. However, the recommendations for<br />
the processing step must be followed meticulously.<br />
Conclusion<br />
The experiments described above show that mineral salts can be<br />
added to milk alternatives without any negative impact on texture or<br />
stability, and that this process can even be exploited to mask various<br />
undesired plant off-notes. Different plants proteins create varied<br />
undesired flavours, so selecting the right mineral salt plays an essential<br />
role in successfully masking such off-notes.<br />
Some mineral salts (e.g. trimagnesium citrate) can even fulfil a dual<br />
function, enhancing flavours on the one hand and helping achieve<br />
fortification claims on the other.<br />
added in small quantities before heat treatment. The levels generally<br />
depend on the type of milk alternative in question, as the different<br />
plant proteins vary in their sensitivity to applied stress in form of heat,<br />
pH changes or shear forces.<br />
Adding tricalcium citrate and trimagnesium citrate after the heating<br />
step to produce a high-magnesium/high-calcium soy yoghurt (in<br />
line with FDA standards) did not have any negative impact on the<br />
yoghurt’s texture, stability or appearance.<br />
The level of magnesium and calcium fortification required for a “high<br />
in calcium/magnesium” claim is higher under the EU standards than<br />
the US standards. Therefore, a test was also carried out to find out<br />
whether the stability and texture of non-dairy yoghurt can be maintained<br />
if even higher levels of mineral salts are added after the heating<br />
stage. Again, this experiment produced soy yoghurt with normal<br />
yoghurt-like stability and texture, demonstrating that high amounts of<br />
minerals can be incorporated into the yoghurt matrix after the heating<br />
step without any detectable loss of stability or texture.<br />
Nowadays, various types of plant proteins are on the rise. Peas are<br />
a particularly common new ingredient for non-dairy yoghurts. The<br />
trials were therefore repeated using a pea-based yoghurt matrix<br />
For more information, please contact<br />
Dr. Sabrina Fischer – Junior Product Manager<br />
sabrina.fischer@jungbunzlauer.com<br />
Miriam Feja – Application Technology Assistant<br />
miriam.feja@jungbunzlauer.com<br />
Jungbunzlauer Ladenburg GmbH<br />
www.jungbunzlauer.com<br />
Regarding non-dairy yoghurt and its complex texture, the experiments<br />
with soy yoghurt showed that mineral salts can be successfully<br />
added – even in large quantities – without having to compromise<br />
on taste, texture or stability of the final product.<br />
References<br />
[1] Hashemi Gahruie, H.; Eskandari, M. H.; Mesbahi, G. & Hanifpour, M. A. Scientific and<br />
technical aspects of yogurt fortification: A review. Food Sci. Hum. <strong>Wellness</strong> 4, 1–8 (2015).<br />
[2] Sethi, S.; Tyagi, S. K. & Anurag, R. K. Plant-based milk alternatives an emerging<br />
segment of functional beverages: a review. J. Food Sci. Technol. 53, 3408–3423 (2016).<br />
[3] Ranadheera, C. S.; Vidanarachchi, J. K.; Rocha, R. S.; Cruz, A. G. & Ajlouni, S. Probiotic<br />
delivery through fermentation: Dairy vs. non-dairy beverages. Fermentation 3, 1–17 (2017).<br />
[4] Chalupa-Krebzdak, S.; Long, C. J. & Bohrer, B. M. Nutrient density and nutritional value<br />
of milk and plant-based milk alternatives. Int. Dairy J. 87, 84–92 (2018).<br />
[5] Gerhart, M. & Schottenheimer, M. Mineral fortification in dairy. <strong>Wellness</strong> <strong>Foods</strong> Eur.<br />
(2013).<br />
[6] Domke, A.; Großklaus, R.; Niemann, B.; Przyrembel, H. & Richter, K. Verwendung von<br />
Mineralstoffen in Lebensmitteln. Bundesinstitut für Risikobewertung (2004).<br />
[7] Harvey, J. A. et al. Superior Calcium Absorption from Calcium Citrate than Calcium<br />
Carbonate Using External Forearm Counting. J. Am. Coll. Nutr. 9, 583–587 (1990).<br />
[8] Kappeler, D. et al. Higher bioavailability of magnesium citrate as compared to magnesium<br />
oxide shown by evaluation of urinary excretion and serum levels after single-dose<br />
administration in a randomized cross over study. BMC Nutr. 3, 1–12 (2017).<br />
[9] Zhu, K. & Prince, R. L. Calcium and bone. Clin. Biochem. 45, 936–942 (2012).<br />
[10] Włodarek, D. et al. Calcium intake and osteoporosis: The influence of calcium intake<br />
from dairy products on hip bone mineral density and fracture incidence – A populationbased<br />
study in women over 55 years of age. Public Health Nutr. 17, 383–389 (2014).<br />
[11] Schumann, L.; Martin, H.-H. & Keller, M. Calcium, Milch und Knochengesundheit.<br />
Behauptungen und Fakten. Ernährung im Fokus 14, 326–331 (2014).<br />
[12] USDA Advisory Committee. Scientific Report of the <strong>2020</strong> Dietary Guidelines Advisory<br />
Committee. (<strong>2020</strong>).<br />
[13] Rene, R. Dairy products, yogurts, and bone health. Am. J. Clin. Nutr. 99, 1256S–1262S<br />
(2014).<br />
[14] U.S. DEPARTMENT OF AGRICULTURE. Soy milk. FoodData Central https://fdc.nal.usda.<br />
gov/fdc-app.html#/food-details/781114/nutrients, accessed on 6th August <strong>2020</strong>.<br />
[15] U.S. DEPARTMENT OF AGRICULTURE. Coconut milk. FoodData Central https://fdc.nal.<br />
usda.gov/fdc-app.html#/food-details/572117/nutrients, accessed on 6th August <strong>2020</strong>.<br />
[16] Gerstner, G. Dairy products: the calcium challenge. Int. Food Ingredients 3, 45–48<br />
(2002).<br />
[17] Younes, M. et al. Re-evaluation of phosphoric acid-phosphates – di-, tri- and polyphosphates<br />
(E 338–341, E 343, E 450–452) as food additives and the safety of proposed extension<br />
of use. EFSA J. 17, 5674 (2019).<br />
[18] Besler, L. & Gerstner, G. Formulating better tasting infant formula. Jungbunzlauer Fact<br />
Sheet (2015).15<br />
38 No. 3 November/December <strong>2020</strong>
Dairy products<br />
Photo ® : Fotolia/emuck<br />
Yogurt Powders: the health benefits of yogurt<br />
with added convenience<br />
Harmony Villemin, on behalf of Epi Ingredients<br />
According to the Codex Alimentarius,<br />
yogurt is a fermented milk characterized<br />
by the use of specific starter<br />
cultures for fermentation, symbiotic<br />
cultures of Streptococcus thermophilus<br />
and Lactobacillus delbrueckii subsp.<br />
Bulgaricus, which shall be viable,<br />
active and abundant ( >10 7 CFU/g ) in<br />
the product throughout its shelf life;<br />
unless the product is heat treated after<br />
fermentation in which case some of<br />
these requirements do not apply.<br />
Although yogurt-making now relies on<br />
standard starter cultures to provide a<br />
consistent product, ensure quality and safety<br />
and meet consumer expectations, it was not<br />
always the case. Evidence of the consumption<br />
of fermented milk dates to ancient times<br />
when fermentation was the result of the spontaneous<br />
activity of native bacteria in milk and<br />
primarily used to preserve it. As such, yogurt<br />
has been a significant part of the human diet<br />
for centuries in many cultures. Not only was<br />
it used to extend milk’s shelf life, but its nutritional<br />
benefits were also recognized early<br />
on and it was consumed for its medicinal<br />
proper ties as early as the Middle Ages to heal<br />
conditions such as diarrhea or burnt skin.<br />
Nowadays, yogurt’s perceived health benefits<br />
are still a major driving force behind<br />
its consumption as increasingly healthconscious<br />
consumers seek simple natural<br />
solutions to support their pursuit of a healthy<br />
lifestyle. Beyond the appeal of its distinctive<br />
tangy flavor, a lot of consumers are attracted<br />
to yogurt for its alleged positive effects on<br />
digestive health, which most people now<br />
understand is the foundation for overall<br />
wellness. Yogurt has indeed become a true<br />
health food staple. It is indeed packed with<br />
the nutrients from milk, such as high quality<br />
protein, calcium, and other valuable vitamins<br />
and minerals, and also contains additional<br />
beneficial compounds resulting from<br />
the microbiota’s metabolic activity, not to<br />
mention the live cultures themselves and<br />
their own positive impact on human health.”<br />
Beneficial health effects of yogurt<br />
Although yogurt and other fermented dairy<br />
products have been consumed for millennia<br />
and often associated with good health and<br />
longevity, it is not until more recently that<br />
scientists began to explore their potential<br />
health benefits. “The lactic acid bacteria<br />
present in fermented milk are suggested to<br />
confer beneficial effects on human health<br />
through the modulation of the intestinal<br />
microbiota, which affects the host either<br />
directly or indirectly.” 1<br />
Yoghurt cultures promote better lactose<br />
digestion<br />
One of the most studied benefit of yogurt<br />
pertains to its role in lactose digestion and<br />
relates to products containing live cultures<br />
of Lactobacillus delbrueckii, Lactobacillus<br />
bulgaricus and Lactobacillus Streptococcus.<br />
The European Food Safety Authority<br />
(EFSA) has even approved the following<br />
generic claim: “yoghurt helps to promote<br />
No. 3 November/December <strong>2020</strong><br />
39
Dairy products<br />
lactose digestion”. A yogurt must contain at least 10 8 CFU/serving<br />
(100 ml minimum) in order to qualify for the use of this health<br />
claim. After reviewing the findings from a number of human trials,<br />
EFSA’s Panel on Nutrition, Novel <strong>Foods</strong> and Food Allergens (NDA)<br />
concluded that improved lactose digestion had a beneficial effect on<br />
individuals with lactose maldigestion.<br />
According to the National Institute of Diabetes and Digestive and<br />
Kidney Diseases, experts have estimated the global prevalence of<br />
lactose malabsorption to affect about 68 % of the global population.<br />
Although asymptomatic in most cases, lactase deficiency can lead<br />
to lactose intolerance which can affect a person’s health and quality<br />
of life by preventing them from getting enough nutrients such as the<br />
calcium or vitamin D present in milk products which contain lactose,<br />
and by causing gastrointestinal troubles such as bloating, gas, diarrhea<br />
and abdominal pain. In such cases, it is however not recommended<br />
to reduce consumption of dairy products as it could lead<br />
to deficiencies in essential nutrients. Instead it is recommended that<br />
lactose intolerant people shift their habits to reduce their consumption<br />
of milk and opt for yogurt and aged cheeses instead. Yogurt is<br />
indeed a great alternative as its lactose content is naturally lower than<br />
that of milk and, even though it still contains significant amounts, the<br />
lactase enzyme produced by yogurt cultures helps people it break<br />
down, thus improving lactose digestion and reducing the discomfort<br />
usually associated with its consumption in lactose intolerant people.<br />
Lactose intolerant people are, however, not the only ones to benefit<br />
from yogurt and associated probiotic bacteria’s consumption.<br />
Yogurt to prevent and cure acute diarrhea in children 2<br />
According to CERIN, the consumption of probiotics, including yogurt<br />
cultures, are an effective way to reduce the risk of acute diarrhea<br />
in children by 57 % on average. It has also<br />
proven to reduce the severity and duration<br />
of diarrhea in children by as much as a day.<br />
Containing about 90 % water, yogurt is great<br />
to keep children hydrated, which is a priority<br />
during acute diarrhea episodes. In developing<br />
countries, the World Health Organization<br />
(WHO) even recommends yogurt to<br />
support children with persistent diarrhea.<br />
Yogurt cultures help regulate the gut<br />
microbiome<br />
The positive effects of consuming yogurt<br />
regularly are often credited to how it<br />
changes the composition of the microbiome.<br />
Although yogurt cultures are only passing<br />
through and do not normally colonize the<br />
gut, when consumed regularly and in sufficient<br />
quantities, they can have a profound<br />
impact on the composition and function of<br />
the gut microbiota such as improving bowel<br />
function, strengthening the immune system,<br />
etc. For example, studies have shown that<br />
regular consumption of yogurt in seniors<br />
suffering from constipation can significantly<br />
improve bowel movement’s frequency and<br />
stool consistency as well as reduce bloating<br />
and abdominal pain usually associated with<br />
constipation.<br />
Compared to other modalities, yogurt<br />
consumption can be a great way to heal mild<br />
gastrointestinal disorders without the negative<br />
effects that can stem from restrictive<br />
diets or antibiotics therapy. Moreover, yogurt<br />
is much more affordable than some of the<br />
other options available on the market and a<br />
completely natural one.<br />
Yogurts and fermented milks potential in<br />
improving metabolic health<br />
“Recent clinical and epidemiological<br />
studies have provided evidence linking<br />
yogurt consumption with a range of systemic<br />
benefits. These include lower body weight<br />
or less weight gain, smaller waist circumference<br />
and lower body fat, improved cardiometabolic<br />
outcomes, and reduced risk of<br />
type 2 diabetes mellitus.” 1<br />
Photo ® : Adobe Stock/Maksim Slesartschuk<br />
With obesity, cardiovascular diseases and<br />
type 2 diabetes rising at an alarming rate<br />
across the world as a result of unhealthy life-<br />
40 No. 3 November/December <strong>2020</strong>
Dairy products<br />
styles, it is paramount to find effective solutions<br />
that can help thwart this growing trend.<br />
Although more studies are needed to get<br />
a better understanding of the full scope of<br />
the metabolic health benefits provided by<br />
the regular consumption of yogurt as well<br />
as its mechanism of action, research points<br />
to the fact that yogurt and fermented milks<br />
consumption could be associated with a<br />
reduced risk of metabolic diseases and<br />
specifically type 2 diabetes.<br />
Research findings suggests that people<br />
consuming at least one yogurt or serving<br />
of fermented milk daily see their risk of<br />
developing type 2 diabetes reduced by<br />
15–20 % compared to individuals who never<br />
or rarely eat yogurt. A study also found<br />
out that yogurt consumption was linked to<br />
healthier lifestyles with participants who<br />
consumed the most yogurt likely to have a<br />
healthier diet overall and less likely to engage<br />
in unhealthy behaviors such as smoking,<br />
overeating or staying inactive. 3<br />
Yogurt’s possible positive impact on other<br />
health conditions<br />
Skin conditions such as eczema or food allergies<br />
can have devastating effects on people’s<br />
quality of life, but recent studies suggest that<br />
yogurt consumption in infancy could reduce<br />
the infant’s likelihood to later develop these<br />
diseases. 4<br />
Other health benefits that yogurt consumption<br />
is thought to provide include promoting<br />
heart health, strengthening the immune<br />
system, or even helping reduce symptoms<br />
of depression. All of which needs to be<br />
confirmed through additional research.<br />
However, it seems safe to say that, overall,<br />
consuming yogurt regularly can only be<br />
beneficial to our health, in more ways than<br />
we know. Thanks to its impressive versatility,<br />
modern consumers can benefit from the<br />
positive health effects of yogurt through a<br />
variety of products and formats that fit every<br />
eating occasion, every lifestyle, and every<br />
food preference. However, one of the main<br />
challenges with fresh yogurt is preservation<br />
and the need for refrigeration!<br />
Photo ® : Adobe Stock/goodluz<br />
The convenience advantage with Epi Ingredients<br />
yogurt powders<br />
The need for refrigeration of fresh yogurt and fermented products<br />
comes with extra costs, can be difficult to achieve in some regions<br />
of the world and does not always fit well in consumers’ increasingly<br />
busy lifestyles and their ongoing quest for convenient, “on-the-go”<br />
healthy options.<br />
As a global leader in the field of dairy processing, Epi Ingredients<br />
tackled this challenge and is proud to make access to fermented<br />
products more convenient through a range of shelf-stable, dry yogurt<br />
ingredients, some of which containing the same live and active<br />
cultures as the ones found in fresh yogurt. EPILAC, whole range of<br />
premium yogurt powders, is the perfect fit for new developments<br />
carrying the healthful halo of yogurt by delivering the same cultures<br />
and thus the same health benefits as their traditional counterparts<br />
but without the need for refrigeration.<br />
Thanks to the company’s strong technological expertise, they were<br />
able to develop a unique manufacturing process allowing them to dry<br />
blends of milk and live cultures, keeping the cultures alive throughout<br />
the process and into the finished powder, if required.<br />
EPILAC powders are also naturally perfectly adapted to regions where<br />
harsh climate conditions might hinder milk production or pose a challenge<br />
when it comes to preserving fresh milk or refrigerated products.<br />
Whether a company is looking for functionality, nutrition or flavor, Epi<br />
Ingredients’ yogurt powders have it all. The company even has the<br />
capabilities and technological expertise to develop taylor-made yogurt<br />
powders to meet their customers specific requirements, whether it is<br />
a custom strain combination or an exclusive flavor profile. Regulatory<br />
experts are also available to support customers when working on the<br />
wording for their packaging.<br />
No. 3 November/December <strong>2020</strong><br />
41
Dairy products<br />
EPILAC premium yogurt powders features:<br />
– Smooth flavor with a pleasant yogurt note<br />
– Natural acidity<br />
– Ease-of-use & versatility<br />
– Clean label<br />
– High microbiological quality adapted to dry mixing<br />
In an effort to go one step further to help their customers, Epi<br />
Ingredients vowed to develop, over the years, a series of on-trend<br />
concepts designed to inspire manufacturers while showcasing the<br />
unique characteristics of its ingredients. Their first concept, awardwinning<br />
SoFlexi, was a versatile powdered mix that allows consumers<br />
to create fresh yogurt-tasting snacks at their convenience. Whether<br />
they are in the mood for a drinking yogurt, some ice cream, or an<br />
acid drink, they can indulge almost instantly thanks to SoFlexi! It was<br />
specifically created to demonstrate possible applications of EPILAC<br />
yogurt powders and, how with a shelf stable product, consumers can<br />
still reap all the health benefits associated with Streptococcus thermophilus<br />
and Lactobacillus bulgaricus active flora.<br />
Beyond powders containing live and active cultures, the EPILAC range<br />
also offers powders featuring inactive flora for brands whose focus<br />
is on flavor more than health benefits. The company also recently<br />
developed new ethnic varieties to quench consumers’ thirst for<br />
adventure and discovery through new flavors. “Consumers interest in<br />
ethnic products is multifaceted and not limited to seeking the excitement<br />
of trying food from another culture.” In fact, consumers also<br />
For more information, please contact<br />
Mathieu Lucot,<br />
Marketing Manager<br />
EPI Ingredients & Laïta Nutrition,<br />
French dairy cooperative Laïta<br />
MLUCOT@laita.fr<br />
value the authenticity and simple processing dictated by the traditional<br />
making of these products. Ultimately, they are also driven by a<br />
quest for wellness, attracted by the high protein content of a variety<br />
or the specific probiotic makeup of another that might provide exclusive<br />
health benefits.<br />
In a nutshell<br />
Although consumed for thousand of years, we are only now starting<br />
to understand and embrace the full potential of yogurt and fermented<br />
dairy products in supporting our health; and even though more<br />
research is needed to uncover additional evidence of their positive<br />
effect on human health, we can say without hesitation that making<br />
yogurt and fermented dairy products a part of people’s daily nourishment<br />
could have tremendous positive repercussions on the global<br />
health status of the world’s population. To make it easier for consumers<br />
to include health-promoting bacteria to their diet consistently, Epi<br />
Ingredients has developed a range of premium yogurt powders<br />
containing the same live and active cultures as fresh yogurt, thus<br />
eliminating the need for refrigeration and opening up a world of possibilities<br />
for brands ready to develop innovative yogurt products.<br />
References<br />
1<br />
Sharon M. Donovan and Robert Hutkins. Introduction to the Fifth Global Summit on<br />
the Health Effects of Yogurt. Nutrition Reviews Vol. 76(S1):1-3. 16 November 2018, doi:<br />
10.1093/nutrit/nuy054<br />
2<br />
CERIN. Ferments laitiers et santé. Publié le 26 décembre 2016, mise à jour le 3 février<br />
2017, https://www.cerin.org/etudes/ferments-laitiers-sante/<br />
3<br />
SYNDIFRAIS. Maladies métaboliques : l’intérêt des yaourts et laits fermentés dans les<br />
régimes adaptés. Nutrition et Produits Laitiers Frais – La Lettre Scientifique et Pratique de<br />
SYNDIFRAIS n°8. Juin 2017.<br />
4<br />
Yogurt in Nutrition. Yogurt is associated with reduced risk of eczema and allergy in infancy.<br />
27 January <strong>2020</strong>. https://www.yogurtinnutrition.com/yogurt-is-associated-with-reducedrisk-of-eczema-and-allergy-in-infancy/<br />
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