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Beyond Echinacea: The Next Generation of Immune Enhancing Compounds

Beyond Echinacea: The Next Generation of Immune Enhancing Compounds. ImmunEnhancer ™ Presentation Bryan Rodriguez & Dr. Steven Witherly. Disclaimer:. † The claims made in this presentation are not intended to diagnose, treat, cure or prevent disease. Immune Products.

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Beyond Echinacea: The Next Generation of Immune Enhancing Compounds

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  1. Beyond Echinacea:The Next Generation of Immune Enhancing Compounds

  2. ImmunEnhancer™ Presentation Bryan Rodriguez & Dr. Steven Witherly

  3. Disclaimer: †The claims made in this presentation are not intended to diagnose, treat, cure or prevent disease.

  4. Immune Products • Immune health continues to be one of the leading consumer interests • Typical delivery (capsules, tablets) • New proposed regulations may eliminate the use of some immune ingredients

  5. Immune Ingredient Opportunity • GRAS affirmed ingredients -proven safety record • Clinical research to support efficacy • Easy to formulate • Multiple ways to deliver -Capsules, tablets (chewable, pressed) -Foods

  6. The Next Generation Immune Ingredient ImmunEnhancer™AGA Safe, Multi-Functional, Immune Modulating†, Ingredient For the Enhancement of Foods and Dietary Supplements

  7. ImmunEnhancerAGOverview • All natural water soluble polysaccharide • Unique to Larix • Found in lumen of cell; no proteins attached • Water extracted without other solvents • Standardized on arabinogalactan -no other actives present • Consistent quality -Not affected by seasonal variability

  8. Raw Material SourceEnvironmentally Friendly Process • Genus: Larix (Larch trees) • Species: occindentalis, laricina • Larch trees on positive growth curve • Lower portion of tree is underutilized by lumber industry due to processing challenges • Wood chips and bark, by-products of process, used in paper and wood products industry • Full utilization of tree

  9. ImmunEnhancerStructure • Highly branched polysaccharide • Arabinose:Galactose = 1:6 • Linkages - Beta (1-3) and Beta (1-6) • Molecular weight by HPLC, 20K Daltons • Readily dispersible and soluble

  10. Gal I Gal I Gal I Gal I Gal I Araf I Gal I Gal I Araf I Araf I Gal - Gal - Gal - Gal - Gal - Gal - Gal - Gal - Gal - Gal - Gal - Gal I Araf I Arap I Araf I Gal I Gal I Gal I Gal I Gal Globular structure of AG in solution Gal = galactose sugar (galactopyranosyl) β(1-3) Main Chain β(1-6) Side Chains Araf = arabinose sugar (arabinofuranosyl) β(1-3) & β (1-6) Arap = arabinose sugar (arabinopyranosyl) = water molecules ImmunEnhancerStructure

  11. ImmunEnhancer Regulatory Status • Nomenclature Larch tree extract, ImmunEnhancerAG, Larch gum Chemical name: arabinogalactan • Regulatory Status FDA approved as food additive FDA GRAS affirmed GRN 000047, GRN 000084 Foreign Approvals Grandfathered under DSHEA • AG Safety Profile Clinically safe results with humans (800+subjects, 1 to 6 months duration) Well tolerated

  12. ImmunEnhancerNutritional Labeling *2000 calorie diet, RDI (Recommended Daily Intake) total dietary fiber is 25g/day.

  13. ImmunEnhancerHuman Clinical Research No adverse reaction in any human clinical: • Health East, 2001, 500 Subjects, 12 Weeks • University of Florida, 2000, 33 Subjects, 6 Weeks • University of Minnesota, 2000, 100 Subjects, 6 Months • SWC Research Institute, 1999, 48 Subjects, 4 Weeks • SWC Research Institute, 1999, 24 Subjects, 4 Weeks • University of Minnesota, 1998, 22 Subjects, 6 Weeks

  14. ImmunEnhancer™AGStructure/Function Claims • Clinically demonstrated immune enhancement† • May increase beneficial immune cell proliferation† • Supports healthy immune system function† • Shown to be more potent (better) than Echinacea due to higher macrophage proliferation†

  15. ImmunEnhancerImmune Health Benefits • Highly effective in promoting, in vitro and in vivo, macrophage proliferation† • Enhancement of natural killer cells† • Supports complement immune system activation† • Increase in beneficial immune cells -monocytes, white blood cells† • Human quality of life inventories increased significantly† • No negative side effects

  16. In Vitro Immune CellProliferation • ImmuneEnhancer™ stimulates macrophage proliferation† • More powerful than Echinacea in side-by-side testing† University of Minnesota, 1997

  17. In Vivo Immune Cell Proliferation (with in vitro PMA mitogen challenge) University of Florida, 2001 215 in vitro 200 120 in vitro Increase (%) 100 13.2 in vivo 0 Lymphocytes Control Lymphocytes 4 g/d AG Monocytes 4 g/d AG

  18. Human Clinical Trial Wellness Profile • Exit interviews supported by clinically relevant SF-36 subject health profiles • Subjects reported improved physical and emotional well-being with increased energy levels† • Subjects wished to retain remaining additional supplements, an excellent sign Southwest Research Institute, 1999

  19. AG SF36 Southwest Research Institute, 1999

  20. ImmunEnhancer Summary • Environmentally friendly • GRAS affirmed immune ingredient • -Excellent safety profile • Well tolerated • Extensive clinical research to support structure/function claims • Increased beneficial immune cells without stimulating pro-inflammatory cells† • Can be taken for short or long term needs

  21. References 1. Effects of Dietary Arabinogalactan on Gastrointestinal and Blood Parameters in Healthy Human Subjects. Robinson, R., Feirtag, J., Slavin, J., JACN, V20, No.4, 279-285 (2001). 2. Effects of Larch Arabinogalactan on Human Peripheral Blood Mononuclear Cells: Results from in vivo and in vitro Human Trials. Causey, J., Robinson, R., Feirtag, J., Fulcher, R., Slavin, J., The FASEB Journal (1999), Part I, 3. Effects of Low-Dose Arabinogalactan From Larix Occidentalis: A Randomized, Double blind, Placebo controlled Pilot Study. Kim, L., Burkholder, P., Waters, R., Comp. Health Practice Review, V7, No.3, S/S 2002 4. Immunological Activity of Larch Arabinogalactan and Echinacea: A Preliminary, Randomized, Double blind, Placebo controlled Trial. Kim, L., Burkholder, P., Waters, R., Altern Med Review 2002;7(2):138-149.

  22. References (continued) 5. Long Term Supplementation of Arabinogalactan in Humans and its Effects on Blood Lipids, Glucose and Insulin. Marett, R., Causey, J., Kessee, L., Slavin, J., The FASEB Journal (2001) 6. Effectiveness of Orange Juice-based Dietary Supplements in Humans. Percival, S., The FASEB Journal (2001). 7. Oral Administration of Arabinogalactan Affects Immune Status and Fecal Microbial Populations in Dogs. Grieshop, C., Flickinger, E., Fahey, G., J. Nutr. 132:478-482, 2002.

  23. ImmunEnhancer AG Product Development Aspects By Steven A. Witherly, Ph.D. TPI

  24. Images: **The trademarks displayed herein are property of the respective owners and are presented for informational / educational purposes.

  25. ImmunEnhancer AGOverview • Physical Characteristics • Sensory Properties • Product Development Applications ** ** **

  26. Calories 1.4kcals/g Sodium 0.2% Total CHO >85% Dietary Fiber >80% Protein <0.5% Fat <0.4% M.W. 20K Daltons Polyphenols 80ppm ImmunEnhancer AGNutritional Information ImmunEnhancer AG

  27. ImmunEnhancer AG Echinacea Mushrooms Astragalus Neutral/Umami Bitter/Sharp Bitter/MSG/Woody Bitter/Woody ImmunEnhancer AGSensory Taste Ingredients

  28. ImmunEnhancerAG Properties: • All Natural ,GRAS, Kosher • Highly H2O Soluble (30 secs.) • CLEAR in Solution! • Up to 60%, w/v • Stable in acid, base beverages • LOW inherent viscosity **

  29. ImmunEnhancerAG Properties: • Fine/agglomerated • Bulk density: 0.3 –0.7g/ml • Moisture < 6% • Microbiological: • SPC <1000 cfu/g • Yeast <10 cfu/g • Mold < 100 cfu/g Many herbs irradiated!!!

  30. ImmunEnhancerAG Advantages • Neutral Taste: good in sweet & savory systems (reduce salt a bit) • Very Stable (unlike most herbs) • Heat • Acids • Non reactive • Reasonably priced • Approved for food use

  31. ImmunEnhancerAG Advantages • Clinical Research on Actual Product, no borrowed science • New FDA guidelines for claims • IDEAL Immune Ingredient!

  32. ImmunEnhancerAG What can you do with it? • Tablets (Compressible, 750 MG) • DISINTEGRANT • COMPACTION AID • Immune Teas (hot & cold) • Capsules (0=500mg; 00=750mg) • Ready to Drink (stable, NO PPT) • Chewable Tablets (1-2 grams) Softgel: not suitable

  33. ImmunEnhancerAG What can you do with it? • Bars (immune recovery, dieting) • Sports bars… • Low Carb bars • Sports Drinks (immune) • Immune systems compromised(1) • Isotonic, Recovery, Protein • Savory Systems • Soups • Breads/Muffins • Immune/herb Blends ** (1) Curr Sports Med Rep. 2003 Apr;2(2):84-90.

  34. Exercise & Immune Response & Antioxidants • Moderate exercise an immune booster, but… • Immune system “undergoes adverse changes after prolonged exertion over 90 minutes…” Immune system is compromised for the next three days. • “Exercise…leads to compromised antioxidant systems…” -Curr Sports Med Rep. 2003 2: 239-42 -Proc Natl Acad Sci USA, 2003, 100: 5119-23

  35. Sports NutritionFormulation idea • Thirst Quencher (Isotonic Drink) ADD: • ImmunEnhancer AG (1-1.5g/16 oz) • Antioxidants (B/C, Vitamin C, & E) 3 Billion Dollars! Also try Sports Food Bar Addition! **

  36. Low Carb Market • Billion Dollar Market, 20% inc/year • ImmunEnhancer AG does not increase insulin levels(2) • Can be added to all Atkin’s-type Foods ** ** (2) J Am Coll Nutr. 2001 Aug;20(4):279-85.

  37. ImmunEnhancerAG Summary • Acts as an Immune Enhancer • Clinical Research Available • Can be Added to just about ANY Food • Approved for Food Use (GRAS) • Neutral in Sensory Profile • Improves Structure of Foods • Shelf life (moisture retention) AS GOOD AS IT GETS!

  38. Formulation Idea Take regular Infant Formula and add: • ImmunEnhancer AG (1.5g/serving) • Probiotic (e.g. LAC 343) ** Superior Infant Nutrition!

  39. Thank You! Dr. Steven Witherly Don’t forget to visit booth # 1713!!! **

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