Presented by: Ram Chaudhari, Ph.D., FACN, CNS Sr ... - Fortitech

Good For Your Guts Foods – Technical PaperPerspectives on Digestive HealthDigestive health problems are a common concern globally and they impose a substantial burdenof morbidity and mortality in many populations. Digestive problems are an important reason forseeking medical care of a physician. Abdominal pain, diarrhea, constipation, vomiting andnausea are responsible for over 20 million outpatient clinic visits, making them the mostimportant gastrointestinal (GI) complaints precipitating visits to US physicians. Theoverwhelming importance of abdominal pain as a presenting symptom and the relativecontribution of each of these other main symptoms are illustrated in Figure 1.Figure 1: Top 5 Gastrointestinal SymptomsPrompting U.S. Outpatient Clinic Visits, 2002Abdominal Pain 59%Diarrhea 19%Vomiting 13%Nausea 11%Constipation 9%Data adapted from: Shaheen NJ et al. The burden of gastrointestinal and liverdisease, 2006. American Journal of Gastroenterology 2006; 101:2128-2138.Health-care costs associated with digestive disease are quite substantial. In the United Statesalone, in excess of $40 billion per year of health-care expenditures are associated withgastrointestinal disease. Medications for digestive disease-related ailments are among the mostcommonly used medications in the United States and account for $10 billion per year in healthcareexpenditures.Good For Your Guts Foods – Technical Paper Page 202.01.08

Common Digestive DiseasesAmong the important digestive diseases, the following diseases are commonly diagnosed:gastroesophageal reflux disease (GERD), gastroenteritis, gastritis, irritable bowel syndrome,diverticular disease and colorectal cancer (Figure 2).600000050000004000000300000020000001000000Figure 2: Physician Diagnosesfor GI Disorders in U.S., 20020GERDGastroenteritisGastritisIrritable Bowel SyndromeDiverticular DiseaseColorectal CancerData adapted from: Shaheen NJ et al. The burden of gastrointestinal and liverdisease, 2006. American Journal of Gastroenterology 2006; 101:2128-2138.Because symptoms of these gastrointestinal diseases are often similar, a brief description ofeach of these GI conditions follow:• Gastroesophageal reflux disease or GERD is caused by an impaired barrier between theesophagus and stomach that allows the reflux of gastric content into the esophagus, whichcauses heartburn, a burning sensation beneath the breastbone, and can lead to mucosaldamage in the esophagus. GERD is the most common digestive disease diagnosis byphysicians in the United States. It accounts for over five million diagnoses annually, andstomach acid-suppressing medications are among the leading selling prescriptionmedications.• Gastroenteritis is a condition usually caused by infection from certain viruses, but it can alsoresult from bacterial infections often due to improperly prepared or bacterially contaminatedfoods (food poisoning). This leads to inflammation of both the stomach and small intestine,which leads to acute diarrhea. Inadequate treatment of gastroenteritis is the cause ofdeath for five to eight million people worldwide annually, and is a leading cause of deathamong infants and children under age five.Good For Your Guts Foods – Technical Paper Page 302.01.08

• Gastritis is inflammation of the stomach mucosa. There are many causes of this condition,including bacterial infection, often from Helicobacter pylori, smoking, excess alcohol andcaffeine consumption, and stress. Symptoms of gastritis include upper abdominal pain ordiscomfort, loss of appetite, nausea and vomiting.• Irritable bowel syndrome is fairly common, accounting for as many as one-half of visits togastroenterologists, and is characterized by abdominal pain associated with frequent boutsof diarrhea, constipation or a change in bowel habits. Since these symptoms overlap withmany other possible conditions affecting the gastrointestinal tract, the diagnosis is made byexclusion of any other evident gastrointestinal abnormalities.• Diverticulosis is caused by an outpouching of the colonic tissue due to an underlyingweakness in the muscle layers beneath the wall of the colon. The incidence of this disease islow in people under age 40, but increases significantly after the age of 40, when 10% ofpeople are known to suffer from diverticulosis, and continues to increase with age to affecthalf of all people over age 60.• Colorectal cancer is caused by cancerous growths in the colon, appendix and rectum.Colorectal cancer is the leading cause of GI-related deaths in the United States. Globally,this cancer accounts for 655,000 deaths each year. However, the incidence of colorectalcancer can vary considerably among different regions of the world, as shown in Figure 3.Figure 3: Incidence Rates for Colorectal Cancer by RegionSouth Central AsiaCentral AmericaChinaEastern EuropeSouthern EuropeNorthern EuropeWestern EuropeNorth AmericaJapan0 10 20 30 40 50Age standardized incidence per 100.000Data adapted from: Parkin DM et al. Global Cancer Statistics, 2002. CACancer J Clin 2005; 55: 74-108.• Inflammatory bowel disease can easily be confused with the more common and similarlysounding irritable bowel syndrome. Inflammatory bowel disease is a more severe conditionthan irritable bowel syndrome. Inflammatory bowel disease is a serious inflammatorycondition that affects the gastrointestinal tract. The two most common forms ofinflammatory bowel disease are called ulcerative colitis, which affects primarily the colonand rectum, and Crohn’s disease, which can affect any part of the gastrointestinal tract, butmostly starts in the ileum, the area of the lower small intestine. One current hypothesis isthat inflammatory bowel disease is caused by an overactive immune system that attacks theintestinal tissue.Good For Your Guts Foods – Technical Paper Page 402.01.08

Aging and Diminished Nutrient UtilizationThe aging of populations around the globe puts an important strain on the health care sectordue to the increase in prevalence of chronic disease in the elderly. Worldwide, it is estimatedthat within the next 20 years there will be one billion people aged 60 years or over. Therecommended micronutrient intake for many essential and nonessential dietary components isincreased in the elderly. For example, governmental recommendations for vitamin D, vitaminB 12 and calcium intake in the elderly population are higher than for younger people. In addition,higher intakes of essential and nonessential antioxidants, such as vitamin C, vitamin E, andvarious antioxidant bioactive food components would likely benefit this older population, due tothe increased risk of chronic diseases that may boost oxidant stress or alter nutrient utilization.However, because daily energy intake usually decreases in older people, while micronutrientrequirements either increase or remain stable, older people have a particularly strong need toconsume more nutrient-rich diets. This can often only be achieved by the use of low-caloriemicronutrient-fortified products or dietary supplements. Moreover, because nutrient absorptionor utilization may be compromised in the elderly, especially among the “oldest old” (≥80y), whoare the fastest growing segment of the elderly population, delivery of highly bioavailablemicronutrients in a low-energy package is especially important.Other prevailing conditions, such as the higher prevalence of digestive diseases in the elderly,may lead to the desire to create micronutrient-fortified food products that are targeted toinclude beneficial disease-specific food components, such as dietary fiber, for example.However, experience shows that the combination of certain types of dietary fiber with somemicronutrients can have a negative impact on micronutrient bioavailability. The complexity ofdeveloping appropriate fortification premixes to, on the one hand, meet specific foodcomponent demands of a new market-targeted product while, on the other hand, maintainingoptimal micronutrient bioavailability and component compatibility can raise difficulties in themanufacturing process that could benefit from consultation with specialists in the micronutrientfortification field.The Gut-Immune System Health ConnectionThere is an intimate connection between a person’s immune system and their gut. Cells of theimmune system are constantly patrolling the gut environment to protect the body fromunwanted bacterial and viral invaders. However, it is increasingly appreciated that there aremany beneficial bacteria living in the colon that are important to a healthy immune system andmay be important in the fight against cancer or other aliments. The delicate balance of bacterialiving in the gut can be affected by a number of factors including antibiotic use and old age.New information also suggests that certain bacteria may have a positive effect beyond the gutby affecting the microecology of the oral cavity, stomach, and vaginal tract. There is increasinginterest in manipulating the body’s microflora to attain certain health benefits.There are three basic approaches that are believed to be able to change the microflora in thelower intestine: probiotics, prebiotics and synbiotics.Good For Your Guts Foods – Technical Paper Page 502.01.08

• Probiotics consist of supplements of live bacteria of naturally-occurring gut bacteria, oftenconsisting of the genera Lactobacillus and Bifidobacterium, which are felt to be beneficial forhealth. Oral delivery of these bacteria is done to help alter the balance of bacteria in thecolon in a more beneficial direction.• Prebiotics are non-digestible food components that can reach the lower GI tract and help toserve as substrates for the growth of beneficial Lactobacillus and Bifidobacterium. Commonprebiotics used in various products include inulin, fructooligosaccharides and lactulose.Studies in young and older healthy adults have shown that prebiotics can help to increasecalcium and magnesium absorption. Studies in infants have shown that prebiotics canpositively affect postnatal immune development and increase fecal secretoryimmunoglobulins. Emerging studies indicate that prebiotics can influence appetite and lipidmetabolism by modulating the secretion of gastrointestinal peptides. Resistant starch,which is a starch that escapes digestion in the small intestine, also has prebiotic propertiesthat can help to promote microbial production of beneficial short-chain fatty acids in thecolon.• Synbiotics represents a novel delivery concept in which a combination of both prebiotics andprobiotics are administered to synergistically obtain a maximum benefit by giving beneficialbacterial strains along with a prebiotic to stimulate their growth.Micronutrients and Bioactive Food ComponentsMicronutrients and various bioactive food components can be of benefit in combatting digestivedisease. For example, diet is well known to be a strong risk factor for colorectal cancer.Individual micronutrients and bioactive food components have been shown in animal cancermodel studies, and in clinical intervention trials, to be efficacious against colorectal cancer. Inparticular, folic acid, calcium and vitamin D are important in lowering the risk of colorectalcancer. Moreover, recent evidence suggests that calcium and vitamin D should be providedtogether to achieve the greatest benefit. Vitamin D, along with omega-3 fatty acids, may alsobe instrumental as anti-carcinogenic nutrients by regulating the proliferative properties of colonprogenitor cells. High intakes of cruciferous vegetables have been specifically associated withlower risks of colorectal cancer. The anti-carcinogenic effect of this subclass of vegetables isoften attributed to their content of glucosinolates, which are inactive themselves but can behydrolyzed to a variety of bioactive compounds, such as isothiocyanates and indoles, by the gutmicroflora. Amino acids, such as glutamine, glutamate, arginine, glycine and histidine may beimportant in promoting gut health. Vitamin A, as well, is important for gut immunity andepithelial integrity.Chronic inflammatory bowel disease is often characterized by alternating periods ofinflammatory flare up, followed by periods of remission. Some randomized clinical interventionstudies have shown that omega-3 fatty acid supplementation can be beneficial in themaintenance of remission in this disease. In addition, the anti-inflammatory properties ofvitamin D support a role for this vitamin in inflammation-based disorders in the GI tract. Clinicalstudies in humans have demonstrated that prebiotic supplementation may be efficacious in thetreatment of mucosal inflammatory disorders, such as inflammatory bowel disease.Good For Your Guts Foods – Technical Paper Page 602.01.08

Probiotics may have a beneficial effect on the type of irritable bowel syndrome that developsafter a bout of infection, and is accompanied by a low-grade inflammation and activation of theimmune system. Another important diet component in the management of irritable bowelsyndrome is dietary fiber. Among the many different types of dietary fiber, water-soluble, nongellingfibers, such as partially hydrolyzed quar gum, have been shown to provide clinicalbenefit to both constipation-predominant and diarrhea-predominant forms of irritable bowelsyndrome.Infectious gastroenteritis is a common cause of death in young children in less economicallydeveloped countries, and causes significant morbidity in more industrialized countries.Dehydration is an important mortality factor in gastroenteritis and acute oral hydration therapyis an essential lifesaving therapy. Additionally, zinc supplementation has been shown to reducethe risk of developing gastroenteritis and lessen the severity of the disease. The addition ofprobiotics may also be of benefit.New Products Aimed at Improving Gut HealthInterest in Gut Health is High: At one point, digestive health was never a topic discussed in‘polite conversation’. That is changing as consumers are becoming more aware of thedevastating tolls associated with poor digestion. Gut health is a major driver in thedevelopment of functional or designer foods around the world. In a recent survey conductedby Health Focus International, one third of the R&D executives surveyed felt that digestivehealth products offered significant opportunities within the next three to five years. Consumerinterest in this product category is also high, according to the report, and sited ‘gastrointestinalproblems’ as the second most important lifestyle item in which consumer response was‘extremely or very concerned’.Gut Health is an Important Concept Area of New and Existing Functional Food Claims: Oneparticularly interesting area of new product innovations in the gut health area is in themarketing of ‘one-a-day’ shots. In an analysis of 525 different one-a-day shots based onpositioning claims, 25% of them used positioning claims based on gut health. Moreover, onehalfof all functional claims on existing food products are related to ‘digestion’.One interesting new combination that has gained some attention is the production of fruitbasedgut health beverage products, rather than traditional dairy-based ones. These productswould combine the already well-accepted antioxidant health benefits of superfruits such as açai,goji, pomegranate and mangosteen, with a healthful combination of prebiotics and probiotics.Formulation and Product ChallengesDigestive health foods and beverages have a tremendous future throughout the world and themarket will continue to grow as new delivery systems are explored, along with the isolation andcharacterization of new strains in foods, supplements and beverages.Good For Your Guts Foods – Technical Paper Page 702.01.08

There are several challenges associated with the use of pre/probiotics, as well as othernutrients in product fortification, which can include:• Finding the optimum balance and choice of proper strain/strains of probiotics. For efficientdigestion and maximum absorption of nutrients, it is essential that the right balance ofmicroorganisms be maintained.• Stability of probiotics at the end of shelf life.• Compatibility of pre/probiotics, along with other components of the finished product.• Possible interaction between ingredients used in the finished product at an elevatedprocessing temperature.• Possibility of cross contamination with pathogenic bacteria. Stringent quality control is amust.• Delivery of nutrients via premix needs special consideration in order to have a homogenousproduct.• The ideal probiotic microorganism should have the following properties:o Nonpathogenico Ability to grow in vivo and vitroo Tolerance to bile acid and gastric acidityo Ability to survive through processing conditionsGood taste, mouthfeel and viable cell counts in the finished product must be monitoredthroughout the shelf life of the product. The ultimate goal is to deliver a nutrient system whichutilizes correct market forms of the highest quality without causing any adverse reaction in thefinished product matrix.More information about nutrient stability can be found at the Fortitech R&D Center in Fortitech’stechnical paper Preserving Nutrient Stability When Adding In-demand Ingredients.Interestingly, current innovations in functional foods with pre/probiotics, including yogurts,beverages, bakery products, breakfast cereal, nutrition bars and other products are emergingwith these healthy ingredients.What Does The Future Hold For Good For Your Guts Food Products?There is substantial and a growing interest in the development of innovative new productsdirected at different segments of the gut health market. A premix fortification approach canhelp manufacturers develop new and innovative gut health products specifically tailored to theneeds and desires of different populations.Two population groups that are potentially fertile areas for specific product development arefoods for seniors and foods for toddlers. The digestive health needs of these groups differ andneed to be addressed in product design and marketing accordingly.Good For Your Guts Foods – Technical Paper Page 802.01.08

Seniors are often plagued by a number of chronic aliments, including problems and concernswith their digestive tract. As previously mentioned, the elderly have increased micronutrientneeds that should be addressed by providing nutrient-rich, low-calorie products. Given the highprevalence of diabetes in the elderly in many parts of the world, these products would benefitby the inclusion of soluble dietary fiber, which will be useful for both controlling blood sugar andcan have positive GI benefits.In addition, research has shown that the balance of gut microflora is altered in the elderly,suggesting a scientific basis for developing new micronutrient-fortified prebiotic and synbioticproducts that help to promote the ecological balance of good bacteria in the gut and also toboost immunity. These products should be provided in a form that is appealing and acceptableto this population. Furthermore, convenience and ease of preparation are essential to thisgroup.Toddlers are another prime target group for the development of new good for your gutsproducts. Parents are less concerned at this age in specific intestinal diseases affecting theirchild, but they are well aware of the importance of promoting a healthy and robust immunesystem in their children, who are likely to come in close and frequent contact with otherchildren in the neighborhood, who may be ill or who may be the source of germs that cancause bouts of gastroenteritis. Children at this age are often ‘picky-eaters’, which increases thestress and concerns of parents about whether their child is receiving proper nutrition. Newmicronutrient-fortified gut health products marketed to emphasize their general immunityboosting potential would likely appeal to parents. Moreover, this target population may beparticularly amenable to the development of new antioxidant-rich, fruit-based, gut healthyjuice-in-the-box-type beverages, or other convenient product types, which would appeal toyounger children and allow for innovative new product development beyond the usual dairyshelf gut healthy alternatives.Optimal Premixes Are The Key To Successful Gut Health Product FormulationAs more manufacturers understand the market possibilities for products that deliver gut healthbenefits, there are a variety of points to consider in the formulation of their products. Whiledairy may be considered an obvious choice as a product delivery vehicle, other methods such asbars, baked goods and even chocolate are all quite viable. However, manufacturers mustremember the importance of the design of their product as it relates to the expectation of theconsumer surrounding how that product should look, feel and taste.To overcome the numerous formulation challenges that need to be addressed to deliver aproduct with great consumer appeal, scientific expertise in the area of fortification technologyand proper ingredient selection needs to come together with marketing throughout the entireproduction process. Both need to rely on the other to ensure the basic four manufacturingcriterion of any successful food product, which include good taste, consistent productquality/texture (mouthfeel), acceptable ingredient stability and adequate shelf life, are all met.Developing a custom nutrient premix specifically geared to a particular delivery vehicle willgreatly reduce the aforementioned challenges and help to ensure success in the marketplace.Good For Your Guts Foods – Technical Paper Page 902.01.08