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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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Presentation Transcript
slide2

ImmunEnhancer™ Presentation

Bryan Rodriguez

&

Dr. Steven Witherly

slide3

Disclaimer:

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

immune products
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

immune ingredient opportunity
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

the next generation immune ingredient
The Next Generation Immune Ingredient

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

slide7

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

raw material source environmentally friendly process
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
immunenhancer structure
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
slide10

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

slide11

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

immunenhancer nutritional labeling
ImmunEnhancerNutritional Labeling

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

immunenhancer human clinical research
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
immunenhancer ag structure function claims
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†

immunenhancer immune health benefits
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
slide16

In Vitro Immune CellProliferation

  • ImmuneEnhancer™ stimulates macrophage proliferation†
  • More powerful than Echinacea in side-by-side testing†

University of Minnesota, 1997

slide17

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

human clinical trial wellness profile
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

slide19

AG SF36

Southwest Research Institute, 1999

immunenhancer summary
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
references
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.

references continued
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.

slide23

ImmunEnhancer AG

Product Development Aspects

By

Steven A. Witherly, Ph.D.

TPI

slide24

Images:

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

slide25

ImmunEnhancer AGOverview

  • Physical Characteristics
  • Sensory Properties
  • Product Development Applications

**

**

**

immunenhancer ag nutritional information
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

immunenhancer ag sensory
ImmunEnhancer AG

Echinacea

Mushrooms

Astragalus

Neutral/Umami

Bitter/Sharp

Bitter/MSG/Woody

Bitter/Woody

ImmunEnhancer AGSensory

Taste

Ingredients

immunenhancer ag properties
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

**

immunenhancer ag properties29
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!!!

immunenhancer ag advantages
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
immunenhancer ag advantages31
ImmunEnhancerAG Advantages
  • Clinical Research on Actual Product, no borrowed science
  • New FDA guidelines for claims
  • IDEAL Immune Ingredient!
immunenhancer ag what can you do with it
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

immunenhancer ag what can you do with it33
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.

exercise immune response antioxidants
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

sports nutrition formulation idea
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!

**

low carb market
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.

immunenhancer ag summary
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!

formulation idea
Formulation Idea

Take regular Infant Formula and add:

  • ImmunEnhancer AG (1.5g/serving)
  • Probiotic (e.g. LAC 343)

**

Superior Infant Nutrition!

slide39

Thank You!

Dr. Steven Witherly

Don’t forget to visit booth # 1713!!!

**