Presented By: Ram Chaudhari, Ph.D., FACN, CNS Sr.

Executive Vice President, Chief Scientific Officer

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Inflammation is at the Root of Many Diseases The realization that chronic, low-grade, tissue inflammation is an important factor in the pathogenesis of a variety of chronic diseases has been an important advancement in the scientific understanding of the mechanism by which the disease is caused. Remarkably, inflammation plays an important role in diseases as apparently diverse as cardiovascular disease, cancer, diabetes, osteoporosis, arthritis, Alzheimers disease, and auto-immune diseases (Figure 1). Moreover, the less dramatic daily discomforts of life, such as chronic pain, depression, memory loss, general cognitive decline, and general muscle fatigue, all seem to be connected in some way to an underlying inflammatory condition. The pharmaceutical industry has developed a myriad of prescription medications and over-the-counter remedies to treat the symptoms associated with these conditions.

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Figure 1. Chronic inflammation is an important risk factor for a variety of chronic diseases and conditions.
Certain Food Components have Anti-Inflammatory Properties An important development in nutritional science in recent years has been the discovery of anti-inflammatory properties of certain nutrients and bioactive food components. There has also been the rediscovery and increased appreciation of the potential value of certain herbs, spices and other botanical-based traditional medicine approaches that may fight inflammation and help in the prevention or treatment of certain diseases or conditions. This paper will highlight some of these important anti-inflammatory nutrients and bioactive components with the intent of increasing awareness of their efficacy and how they may be incorporated into the development of novel anti-inflammatory fortified-food products.

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Growing Public Awareness of Anti-Inflammatory Benefits of Certain Foods The general public is less aware of the importance of dietary anti-inflammatory nutrients than they should be, but there has been a growing awareness of this concept among the more health-conscious consumer. The latter group has likely gained this awareness from the many positive news reports of the health benefits associated with fish consumption and the role of omega-3 fatty acids, such as DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid) in reducing inflammation. It is important that this consumer momentum and awareness about anti-inflammatory nutrients is capitalized upon and expanded in the future and that it not be somehow lost among the increasing health concerns associated with mercury and other environmental contaminants found in certain fish species. The availability of a variety of novel, consumer-acceptable omega-3 fatty acid-fortified food products, as an alternative to fish consumption, as a source of these important healthy fatty acids will likely be a growth opportunity, as well as the development of other novel antiinflammatory food products. The diseases and adverse health conditions mentioned above affect both males and females and are of obvious special concern in older adults, who more likely suffer from, or are increasingly aware of, the issue of chronic disease and disability. In many cases, the search for anti-inflammatory remedies is driven by an effort to relieve chronic pain, as may be associated with common conditions such as arthritis. Anti-Inflammatory Drugs are Big Business According to the market research company BCC Research, the market for anti-inflammatory drugs was projected to be $35.5 billion in 2010. Among the diseases associated with the use of anti-inflammatory medications, the most common are asthma and chronic obstructive pulmonary disease, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and psoriasis (Figure 2).

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Figure 2. Diseases associated with the use of anti-inflammatory drugs in 2010. http://www.bccresearch.com/report/PHM048A.html Accessed online July 17, 2011.
The older adult group is a clear target for anti-inflammatory remedies. In this regard, from a geographic perspective, certain areas of the world with a very high proportion of elderly, such as Japan, Europe and the United States, may be particularly strong places to engage in anti-inflammation-based marketing strategies for fortified products. Nevertheless, it should be realized that a strong scientific case can be made that chronic inflammation should be a concern throughout the life span. For example, there is increasing awareness in the scientific community that the conditions for chronic disease are actually in many ways set in early development, including during fetal life. This is sometimes referred to as

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metabolic programming or imprinting and is an active area of current research and discovery. Thus, in one sense, it is never too early in the life cycle to consider the possible benefits of controlling inflammation. It is evident, for example, that inflammation in the pregnant mother can have adverse effects on pregnancy outcome. Likewise, the explosion in childhood obesity in both developed and developing nations is marked by an important underlying component of low-grade, chronic inflammation, called metaflammation, that could set the stage for the development of more adverse health outcomes in the future, such as an increased risk of developing heart disease and type 2 diabetes. Chronic Pain is an Important Public Health Problem Important market drivers for anti-inflammatory products include increasing consumer awareness of the connection between good nutrition and health. This includes the notion that there are specific nutrients and ingredients that have special functional properties needed to improve health and prevent the onset of disease. On an individual level, a significant segment of society lives with some sort of chronic pain and discomfort, as well as an awareness that the stresses of everyday life may lower immunity and increase susceptibility to infections. According to a recently released report from the Institute of Medicine, 116 million Americans suffer from chronic pain. This is more people than are affected by heart disease, diabetes and cancer combined. Thus, pain management is an important public health issue. Pain-associated medical costs in the United States are estimated to be $560-635 billion per year. Since inflammation is often an important component of the pathology of pain-producing conditions, the availability of effective anti-inflammatory treatments and preventatives is imperative in fighting this condition. In Demand Anti-Inflammatory Nutrients There is extensive literature available on the general anti-inflammatory properties of various nutrients, food-derived components, herbs and various botanicals. Moreover, some of these dietary components have been tested, related to the treatment of specific inflammation-based diseases. For example, conjugated linoleic acid (CLA) and omega-3 polyunsaturated fatty acids have been shown to be effective in animal models of inflammatory bowel disease, but there are not strong clinical findings, as yet, to support the efficacy of these nutrients in combating this condition in patients.1 Much of the available scientific literature is limited to pre-clinical studies in cell culture or animal models. Increasingly, however, the antiinflammatory properties of some of these nutrients and foods are being identified by examining dietary patterns in epidemiologic studies and some have been explored more directly in clinical studies. For example, a typical Mediterranean-style diet that is rich in monounsaturated fatty acids compared to saturated fatty acids, has a high ratio of omega-3-to-omega-6 polyunsaturated fatty acids, with an abundance of fruits, vegetables, legumes and grains has an anti-inflammatory effect when compared to a typical Western style diet.2 It will be a more difficult, however, to fully elucidate which specific components of the Mediterranean diet are responsible for these findings.3
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Access nutrient monographs at fortitech.com to learn more about incorporating these ingredients in your food or beverage product.

It also should be noted that there will likely be a strong interaction between a persons genetic makeup and their response to specific dietary components. The emerging area of nutritional genetics (nutrigenomics) and personalized nutrition will likely be a major research theme throughout the 21st century as we try to unravel and understand the complex interplay of various individual genetic alterations and environmental exposures, including diet, and specific health risks. An example of this phenomenon that is relevant to our current topic is the finding that the apolipoprotein E4 (apoE4) genotype, which is a significant genetic marker of risk for cardiovascular and Alzheimers disease, is associated with a more pro-inflammatory state, which may be related to the apparent effect of the apoE4 genotype on the metabolism and retention of vitamin E, an important antioxidant vitamin.4 Moreover, it might be important to consider that the most beneficial aspects of certain dietary components could be evident only within the context of other dietary constituents or conditions. For example, a recent review of clinical studies5 investigating the role of dietary fiber on C-reactive protein, an important inflammatory biomarker, found that increased dietary fiber consumption reduced C-reactive protein; however, these studies were also associated with weight loss and altered dietary fatty acid composition, which could confound these effects. Future clinical studies will need to carefully parse the individual contributions of dietary fiber on inflammation, as well as the potential combinatorial benefits of various dietary changes on this condition. The following sub-sections provide an overview of some peer-reviewed clinical intervention trials that have studied the anti-inflammatory properties of various nutrients and food factors under a variety of conditions and in healthy and diseased populations. A summary of these anti-inflammatory factors is provided in the following Table. More detail concerning the specific clinical trial can be found in the text below. Table. Anti-Inflammatory Foods, Nutrients and Bioactive Factors Used in Clinical Trials Juices Bilberry Orange Tomato Blackcurrant Vitamins Vitamin A Vitamin C Vitamin D Vitamin E Riboflavin Niacin Botanicals, Spices Japanese Knotweed Curcumin Grape Seed Extract

Minerals Zinc Selenium Manganese Chromium

Bioactives Quercetin EGCG Soy Isoflavones eta-Carotene L-Carnitine CoQ 10 Probiotics

Fatty Acids DHA EPA Arachidonic Acid

Fruits and Vegetables: Evidence from clinical trials supports a beneficial role of polyphenol-rich fruit and vegetable extracts or juices on inflammatory biomarkers. For example, a randomized, control trial of bilberry juice (1 L per day x four weeks) consumption6 compared to water (control) in 62 adult male and female Norwegian subjects at risk of cardiovascular disease indicated a significant salutary effect of bilberry juice on C-reactive protein
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and several other biomarkers of inflammation. Similarly, a Danish study7 investigating the effects of orange (250 mL per day) and blackcurrant juice (250 mL per day) compared to a sugar drink (placebo) on inflammatory markers in 48 patients with peripheral arterial disease observed that following a 28-day treatment period there was a significant decrease in inflammatory markers due to the juice treatment. Spanish investigators found that consumption of tomato juice containing 21 mg lycopene for two weeks resulted in a significant reduction in C-reactive protein, a marker of inflammation.8 In a clinical trial of 117 healthy adults conducted in the United States, researchers found that consumption of encapsulated fruit and vegetable juice powder concentrate for 60 days had a positive effect on various inflammatory biomarkers.9 In another study, researchers in the United Kingdom investigated the effects of grape seed extract, a flavonoid-rich product, as a potential mediator of inflammation in 32 patients with type 2 diabetes.10 Patients received either GSE (600 mg per day) or placebo for four weeks in a double-blind crossover study. GSE treatment caused a significant reduction in inflammation measured by serum C-reactive protein biomarker. A similar study in healthy pre- and post-menopausal women, conducted in the United States, found that consumption of 36 g of lyophilized grape powder for four weeks caused a significant reduction in serum tumor necrosis factor-alpha (TNF-), an important cytokine that can trigger the inflammatory response.11 Other investigators in the United States have recently reported that six weeks of treatment with an extract of polygonium cuspidatum (Japanese Knotweed) that contained 40 mg resveratrol suppressed biomarkers of inflammation in healthy, normal-weight subjects.12 In addition to trials of juices and botanical extracts on inflammation, studies have also investigated the effect mixtures of purified bioactive compounds on inflammation. For example, Neiman and colleagues13 studied the effect of a bioactive mixture in trained cyclists on exercise-induced inflammation. Forty cyclists were randomized to placebo, quercetin (1000 mg), or a mixture of quercetin plus 120 mg epigallocatechin 3-gallate (EGCG), 400 mg isoquercetin, and 400 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for two weeks before, during, and one week after three days of heavy exercise exertion. The bioactive mixture caused a significant reduction in biomarkers of inflammation immediately after the exercise bout. Curcumin is a traditional Indian spice that has gained much interest as a potential antiinflammatory compound. A recent clinical study from Japan has investigated whether a combination of soy isoflavones and curcumin could influence the blood levels of prostate specific antigen (PSA) in men who had elevated PSA, but who did not have evidence of prostate cancer based on a negative prostate biopsy.14 Eighty-five men were randomized to receive either placebo or soy isoflavone-curcumin for six months. Changes in PSA, a marker of prostate inflammation, was evaluated before and after supplementation, and the investigators found that the mixture significantly reduced serum PSA concentrations. A study conducted in India with 72 patients with type 2 diabetes found that 300 mg curcumin for eight weeks caused a significant reduction in biomarkers of inflammation in the blood.15 Omega-3 fatty acids, such as EPA and DHA, have been shown to have significant antiinflammatory effects in pre-clinical studies in cell culture, in animal studies and in observational studies in human populations. Surprisingly, however, clinical studies confirming the
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direct beneficial effects of omega-3 fatty acid supplementation on biomarkers of inflammation are generally lacking. Thus, the anti-inflammatory effect of omega-3 fatty acids is controversial. However, a recent Swedish study of obese adolescents has provided information that omega-3 fatty acid supplementation (1.2 g per day x three months) was associated with lower serum biomarkers of inflammation.16 Due to its powerful antioxidant properties, vitamin E has important potential as an antiinflammatory agent. In a recent study published in the New England Journal of Medicine, investigators studied the effects of vitamin E (800 IU per day x 96 weeks) on non-alcoholic fatty liver inflammation (non-alcoholic steatohepatitis), a common liver disease, in adults without diabetes and found that vitamin E treatment was associated with a significantly higher rate of improvement in non-alcoholic steatohepatitis compared to placebo and a reduction in markers of liver inflammation.17 In a small study of 13 older Italian men with impaired fasting glucose, investigators found that treatment with 1000 IU vitamin E and 1000 mg vitamin C for four weeks reduced blood levels of TNF-, an indicator of inflammation.18 In another study, subjects with metabolic syndrome, which is associated with an increased risk of diabetes and cardiovascular disease, were randomized to 800 IU per day of alpha-tocopherol or 800 IU gamma-tocopherol, or a combined vitamin E treatment or placebo for six weeks. C-reactive protein concentration and serum TNF- was significantly reduced by the combined treatment and TNF- was also reduced by alpha-tocopherol treatment alone.19 Mixtures of antioxidant nutrients have also been investigated for their effects on inflammation in various disease conditions. For example, recently investigators in the United States found that a combination of alpha-tocopherol (800 mg), beta-carotene (24 mg), vitamin C (1000 mg), selenomethionine (0.2 mg), riboflavin (7.2 mg), niacin (80 mg), zinc (60 mg), and manganese (5 mg) consumed daily for four months in patients with a history of sporadic colorectal adenoma had a beneficial effect on markers of inflammation and oxidative stress.20 Asthma is another inflammatory disease where nutrition may be able to play an ameliorating role. A study from Egypt randomly assigned 60 children with asthma to either placebo or a nutrient supplement containing omega-3 fatty acids, vitamin C and zinc and found that there was significant improvement in pulmonary function tests and inflammatory markers.21 In a recent study from Iran, 36 patients on hemodialysis were randomized to receive either placebo or 1000 mg per day L-carnitine for 12 weeks.22 The investigators found that carnitine supplementation was associated with a significant reduction in C-reactive protein and the pro-inflammatory cytokine IL-6. A study of zinc supplementation in 40 healthy elderly subjects in Detroit found that 45 mg zinc per day for six months decreased the concentration of serum C-reactive protein and various other inflammatory biomarkers.23 An Iranian study in 60 obese prepubescent children found that supplementation with 20 mg zinc for eight weeks was associated with a significant decrease in serum C-reactive protein. Overall, the studies highlighted above represent clinical intervention trials which demonstrate the efficacy of various nutrients and bioactive food factors or botanical sources as anti-inflammatory ingredients.

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Product Applications A wide variety of delivery vehicles for anti-inflammatory factors in fortified food products is possible. These include a variety of traditionally fortified foods and dietary supplements. In addition, snack foods and beverages should be readily amenable to fortification with antiinflammatory nutrients and bioactive factors. The wide spectrum of anti-inflammatory ingredients highlighted above should provide significant flexibility and many opportunities to incorporate these nutrients and bioactives in many different product types. There will be, of course, specific fortification and formulation challenges that will arise with any specific product where professional advice will be helpful. Fortification and Formulation Challenges Food and beverage manufacturers worldwide recognize that delivering nutrient value can open market opportunities and drive sales. Competitive edge can be won through factors including functional ingredient load, health claims and product customization for specific demographics and health conditions. The key to manufacturers ability to meet the promise of their nutritional labels and health claims is the stability of the nutrients in their food or beverage matrix. There are, however, many variables internal and external to the products environment that affect nutrient integrity, potentially limiting their potency, efficacy and shelf-life. It stands to reason, too, that the affects of these variables are compounded as the number of functional ingredients being integrated increases. When designing a food or beverage, it is essential to consider few basic factors as a foundation for optimizing nutrient stability:

nutrient activity/bioavailability composition of the finished food manner of addition processing condition and procedures storage and other conditions prior to consumption regulatory status of nutrients purity of ingredients stability and safety aspect of nutrients

Prototypes - Formulations Beverage (Fruit Flavored/Ready-to-Drink) Nutrients Vitamin A Vitamin E Vitamin C Selenium Zinc Chromium Bilberry Extract Grape Seed Extract Per Serving 2500 IU 15 IU 60 mg 70 mcg 3 mg 45 mcg 10 mg 50 mg

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Vitamin B6 Vitamin B12 Folic Acid Sprinkles (Stick Pack) Nutrients Curcumin (Turmeric Extract) Quercetin CoQ 10 Soy Isoflavone EGCG Vitamin C Vitamin E

2 mg 6 mcg 200 mcg

Per Serving 50 mg 150 mg 100 mg 100 mg 50 mg 30 mg 30 IU

Strawberry Smoothie (Any Fruit Smoothie) Nutrients Vitamin A Vitamin D Omega-3 Resveratrol Arachidonic Acid L-Carnitine EGCG Folic Acid Vitamin B6 Vitamin B12 Lycopene Glutamine Vitamin E Vitamin C Selenium Zinc Magnesium Bilberry Extract Riboflavin Niacinamide Nutrition Bar Nutrients Vitamin A (Beta-Carotene) Vitamin D Vitamin E Vitamin C Vitamin B1 Vitamin B2 Niacinamide Calcium Pantothenate
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Per Serving 1000 IU 200 IU 150 mg 50 mg 25 mg 50 mg 50 mg 200 mcg 1 mg 3 mcg 3 mg 200 mg 30 IU 30 mg 70 mcg 3 mg 100 mg 10 mg 0.5 mg 5 mg

Per Serving 2500 IU 100 IU 30 IU 30 mg 0.5 mg 0.7 mg 5 mg 3 mg

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Vitamin B6 Vitamin B12 Folic Acid Selenium Zinc Magnesium CoQ 10 Omega-3 Future Trends

1 mg 3 mcg 200 mcg 70 mcg 5 mg 200 mg 10 mg 100 mg

An important pathologic role of inflammation in many important chronic diseases and conditions, such as obesity, is strongly supported by scientific literature. With the predicted explosion of the elderly population in many countries and the growing obesity epidemic in both developed and developing countries, there will be a growing market for products that can deliver efficacious doses of anti-inflammatory nutrients and bioactive compounds. Market opportunities may develop in less than traditional areas. For example, novel food delivery vehicles for anti-inflammatory compounds could be contemplated that directly provide these anti-inflammatory factors to the site of infection and inflammation. An example of this application would be in periodontal disease or mouth sores where incorporating anti-inflammatory factors in chewing gum, toothpaste, dental adhesives, oral sprays or hard candies could be therapeutically beneficial. Additional niche target groups, such as active exercisers, body builders and sport players, may find addition of anti-inflammatory factors to energy and sport drinks appealing, while the overweight person on a diet could benefit by anti-inflammatory compounds in low-cal drinks or in high-fiber bars or other foods. Likewise, non-food items, such as topical skin applications or shampoos enriched with natural anti-inflammatory compounds could have some benefit in inflamed skin lesions, such as acne or psoriasis, or for use in sun-protection lotions to reduce the pain and irritation associated with sunburn. Literature Cited 1. Bassaganya-Riera, J., Hontecillas, R. Dietary conjugated linoleic acid and n-3 polyunsaturated fatty acids in inflammatory bowel disease. Current Opinion in Clinical Nutrition & Metabolic Care, 13:569-73. 2. Galland, L. Diet and inflammation. Nutrition in Clinical Practice, 25:634-40. 3. Calder, P.C., Albers, R., Antoine, J.M., et al. (2009). Inflammatory disease processes and interactions with nutrition. British Journal of Nutrition, 101 Suppl 1:S1-45. 4. Huebbe, P., Lodge, J.K., Rimbach, G. Implications of apolipoprotein E genotype on inflammation and vitamin E status. Molecular Nutrition & Food Research, 54:623-30. 5. North, C.J., Venter, C.S., Jerling, J.C. (2009). The effects of dietary fiber on C-reactive protein, an inflammation marker predicting cardiovascular disease. European Journal of Clinical Nutrition, 63:921-33. 6. Karlsen, A., Paur, I., Bohn, S.K., et al. Bilberry juice modulates plasma concentration of NF-kappaB related inflammatory markers in subjects at increased risk of CVD. European Journal of Clinical Nutrition, 49:345-55. 7. Dalgard, C., Nielsen, F., Morrow, J.D., et al. (2009). Supplementation with orange and blackcurrant juice, but not vitamin E, improves inflammatory markers in patients with peripheral arterial disease. British Journal of Nutrition, 101:263-9.

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8. Jacob, K., Periago, M.J., Bohm, V., Berruezo, G.R. (2008). Influence of lycopene and vitamin C from tomato juice on biomarkers of oxidative stress and inflammation. British Journal of Nutrition, 99:137-46. 9. Jin, Y., Cui, X., Singh, U.P., et al. Systemic inflammatory load in humans is suppressed by consumption of two formulations of dried, encapsulated juice concentrate. Molecular Nutrition & Food Research, 54:1506-14. 10. Kar, P., Laight, D., Rooprai, H.K., Shaw, K.M., Cummings, M. (2009). Effects of grape seed extract in Type 2 diabetic subjects at high cardiovascular risk: a double blind randomized placebo controlled trial examining metabolic markers, vascular tone, inflammation, oxidative stress and insulin sensitivity. Diabetic Medicine, 26:526-31. 11. Zern, T.L., Wood, R.J., Greene, C., et al. (2005). Grape polyphenols exert a cardio protective effect in pre- and post-menopausal women by lowering plasma lipids and reducing oxidative stress. Journal of Nutrition, 135:1911-7. 12. Ghanim, H., Sia, C.L., Abuaysheh, S., et al. An anti-inflammatory and reactive oxygen species suppressive effects of an extract of polygonum cuspidatum containing resveratrol. The Journal of Clinical Endocrinology & Metabolism, 95:E1-8. 13. Nieman, D.C., Henson, D.A., Maxwell, K.R., et al. (2009). Effects of quercetin and EGCG on mitochondrial biogenesis and immunity. Medicine & Science in Sports & Exercise, 41:1467-75. 14. Ide, H., Tokiwa, S., Sakamaki, K., et al. Combined inhibitory effects of soy isoflavones and curcumin on the production of prostate-specific antigen. Prostate, 70:1127-33. 15. Usharani, P., Mateen, A.A., Naidu, M.U., Raju, Y.S., Chandra, N. (2008). Effect of NCB02, atorvastatin and placebo on endothelial function, oxidative stress and inflammatory markers in patients with type 2 diabetes mellitus: a randomized, parallel-group, placebocontrolled, 8-week study. Drugs in R&D, 9:243-50. 16. Dangardt, F., Osika, W., Chen, Y., et al. Omega-3 fatty acid supplementation improves vascular function and reduces inflammation in obese adolescents. Atherosclerosis; 212:580-5. 17. Sanyal, A.J., Chalasani, N., Kowdley, K.V., et al. Pioglitazone, vitamin E, or placebo for non-alcoholic steatohepatitis. The New England Journal of Medicine, 362:1675-85. 18. Rizzo, M.R., Abbatecola, A.M., Barbieri, M., et al. (2008). Evidence for anti-inflammatory effects of combined administration of vitamin E and C in older persons with impaired fasting glucose: impact on insulin action. Journal of the American College of Nutrition, 27:505-11. 19. Devaraj, S., Leonard, S., Traber, M.G., Jialal, I. (2008). Gamma-tocopherol supplementation alone and in combination with alpha-tocopherol alters biomarkers of oxidative stress and inflammation in subjects with metabolic syndrome. Free Radical Biology & Medicine, 44:1203-8. 20. Hopkins, M.H., Fedirko, V., Jones, D.P., Terry, P.D., Bostick, R.M. Antioxidant micronutrients and biomarkers of oxidative stress and inflammation in colorectal adenoma patients: results from a randomized, controlled clinical trial. Cancer Epidemiology, Biomarkers & Prevention, 19:850-8. 21. Biltagi, M.A., Baset, A.A., Bassiouny, M., Kasrawi, M.A., Attia, M. (2009). Omega-3 fatty acids, vitamin C and Zn supplementation in asthmatic children: a randomized self-controlled study. Acta Paediatrica, 98:737-42. 22. Shakeri, A., Tabibi, H., Hedayati, M. Effects of L-carnitine supplement on serum inflammatory cytokines, C-reactive protein, lipoprotein (a), and oxidative stress in hemodialysis patients with Lp (a) hyperlipoproteinemia. Hemodialysis International, 14:498-504. 23. Bao, B., Prasad, A.S., Beck, F.W., et al. Zinc decreases C-reactive protein, lipid peroxidation, and inflammatory cytokines in elderly subjects: a potential implication of zinc as an atheroprotective agent. The American Journal of Clinical Nutrition, 91:1634-41.
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