Immunity and Functional Ingredients

Challenges and Opportunities for the Food & Supplement Industries

Roger Clemens, DrPH, CNS, FACN, FIFTUSC School of PharmacyThe E.T. Horn Company

Clemens@usc.edu1

Let food be thy medicine, thy medicine shall be thy food.

- Hippocrates

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Immunity and Functional Foods

Trends/Opportunities

• The food industry = subset of medicine

• More than one-third (36%) of consumers desire to reduce their risk of developing health conditions

• Approximately 30% of consumers follow their doctor’s medical advice, while 25% manage/treat a specific health condition on their own Food Mktg Institute. 2006

www.fmi.org 3

Trends/Opportunities

2008 Survey of 1,000 Americans Aged 18+

• 76% believe that specific foods/beverages can “maintain overall health and wellness.”

• 92% are currently consuming or are interested in consuming foods/beverages that “maintain overall health and wellness.”

Study conducted Feb 21-March 11, 2008 via Web-based surveywww.ific.org

International Food Information Council

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Trends and Opportunities

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87%

Trends and Opportunities

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Growth of Functional Foods

• The U.S. market for functional foods and beverages is the largest in the world.

• U.S. sales are expected to reach $33.3 billion this year -- one-third of total global sales.

7Source: Food Product Design, July 2008.

Health Benefits & Antioxidants

Nutraceuticals World, 2007 8

Opportunity - Caution

When companies claim their products will “maintain a healthy immune system,” consumers believe this means those products will help ward off disease. But while vitamins A, C, and E are important for the functioning of just about every system in the human body, there's little evidence to suggest that drinking Crystal Light will have any impact on the average person's immune system.

-- www.healthnewstrack.com / July 6, 2008

U.S. Center for Science in the Public Interest

urges FDA to crack down on food frauds

Arbitrary addition of immune health claims arebecoming the focus of negative press.

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Health Claims for Conventional Foods and Dietary Supplements

• Health claims– Describes a relationship between a

substance (food, food component, or dietary supplement ingredient), and reducing risk of a disease or health-related condition

– Truthful and non-misleading

www.cfsan.fda.gov/~dms/hclaims.html

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Health Claims for Conventional Foods and Dietary Supplements

• Health claims– Significant Scientific Agreement (NLEA

Authorized Health Claims)– Authoritative Statements (foods, not

dietary supplements)– Qualified Health Claims (emerging

“limited” evidence)

www.cfsan.fda.gov/~dms/hclaims.html

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Health Claims for Conventional Foods and Dietary Supplements

• Health Claims– Nutrient Content Claims

• Describes nutrient level: – e.g., free, high, low, more, reduced, lite

– Structure/Function Claims• Describes role of a nutrient or dietary

ingredient intended to affect normal structure or function

– e.g., “fiber maintains bowel regularity”www.cfsan.fda.gov/~dms/hclaims.html

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Research Remains Gold Standard

“Research is to see what everybody else has seen, and to think what nobody

else has thought.” Albert Szent-Gyorgyi,

1937 Nobel Prize for Medicine

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NutraFlora® Supports Immune Health• Study

– Subjects: Severe acute pancreatitis (n=30)– Enteral feed: 2000 kcal/d; 125 kcal/100 mL– Intervention: 0.7 g soluble fiber/100 mL

• Outcome– CRP (mg/L) [C-reactive protein]– APACHE II (score) [Acute Physiology and Chronic Health Evaluation II]– Balthazar CT (score) [Computed Tomographic Severity Index (Balthazar

Score) in Acute Pancreatitis ]

Karakan T et al., World J Gastroenterol 2007;13(19)2733-37

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NutraFlora® Supports Immune Health

Karakan T et al., World J Gastroenterol 2007;13(19)2733-37

Outcomes* Study Group Control Group P value

CRP, mg/L 7 2 10 3 < 0.05

APACHE II Score 4 2 6.5 3 < 0.05

CT Score 12 4 16 3 < 0.05

* Normal values: CRP negative, APACHEII < 8; CT Score = 0-1

Conclusion: Parenteral feed with prebiotic fiber improved clinical outcomes, decreased hospital stay, acute phase response and overall complications.

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Cold Flu Study 2007• Study healthy community-dwelling subjects• Double-blind placebo controlled• Wellmune WGP and placebo for 90 days• Assess number, severity, duration of Severe

Respiratory Infections (SRIs)• Assess overall health, sick days, effect on symptoms• 40 subjects

Wellmune WGP® Reduces Cold/Flu Symptoms

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http://www.wellmune.com/coldflustudy2008.htm

Study Summary

No safety concerns in study (CBC, kidney, liver tests)

Wellmune WGP Reduces Cold/Flu Symptoms

http://www.wellmune.com/coldflustudy2008.htm

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Study #2 - Physical stress study• 75 subjects (25 runners per group) at

Carlsbad Marathon• Double-blinded, placebo-controlled

Wellmune WGP® Reduces Stress-Related Health Challenges

Study #1 - Lifestyle stress study• 150 Subjects (50 per group)• Selected using Stress-level questionnaire

– Moderate to high life style stress– Stress criteria included job, sleep, diet,

sex & weight• Double-blinded, placebo-controlled

Protocol

•One daily dose each morning (250 mg or 500 mg)

– Prior research indicates 2 mg Wellmune WGP per kg bw

•Doses given every morning for four weeks

•Health Questionnaire focusing on (1) upper respiratory tract infection (URTI) Symptoms & (2) daily health log of overall physical health

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Subjects Reporting URTI Symptoms

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Placebo 250mg Wellmune 500mg Wellmune

Nu

mb

er

of

Su

bje

cts

Week 2

Week 4

66% Fewer Upper Respiratory Tract Infection Symptoms in Healthy-Stressed Subjects (Marathoners)

*P<0.05

* * * *

Study #2 - Physical stress study

19http://www.wellmune.com/marathonerstudy.htm

Profile of Mood States (POMs)

• Well validated survey instrument used in > 2,900 trials• Employs 65 adjective-based indicators of mood scaled 0-4• Specific combinations of adjectives define specific mood state

factors• Tension, Vigor, Fatigue, Confusion, Anger and Depression

Factors

Study #2 - Physical stress study

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http://www.wellmune.com/marathonerstudy.htm

• Subjects reported 38% decrease in Tension Factor at 250 mg daily dose

• Subjects reported 22% increase in Vigor Factor at 250 mg daily dose

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POMS Tension Factor

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Placebo 250mgWellmune

500mgWellmune

PO

MS

Sco

re Baseline

Week 2

Week 4** *

POMS Vigor Factor

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Placebo 250mgWellmune

500mgWellmune

PO

MS

Sco

reBaseline

Week 2

Week 4

* **

Study #2 - Physical stress study

http://www.wellmune.com/marathonerstudy.htm

With Wellmune WGP:

• Subjects realize both physical and psychological • URTI symptoms decrease and overall physical health improves• People “feel” better because they are healthier (POMS results

are logical)• High levels of stress can negatively affect ability to maintain

good health

When people are experiencing heavy physical or psychological stress, Wellmune WGP may offer significant benefits.

Summary of Wellmune Stress Studies

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Immune Benefits of Tea

Kamath AB et al., PNAS 2003;100(10):6009-14

Ingestion of tea containing ethylamine (EA) causes PBMCs (peripheral blood mononuclear cell) to produce IFN- in response to heat-killed bacteria in-vivo.

In vitro priming by pre-treating PBMCs with ethylamine , then washing it away, followed by stimulation with killed bacteria

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Predictions

“Our lives are not in the lap of the gods, but in the lap of our cooks.”

- Lin Yutang

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Functional Food Predictions 2008

• Healthy Household– Greater family health

concerns• Naturally Functional

– Natural “color” superfruits• Balancing “Bul-get”

– Satiety, lite foods, portion size

• Contemporary Conditions– Aging, wrinkles health

concerns• Proactive Lifestyles

• Simpler, Greener, Cleaner– “fresh, “natural” = farm, additive

free, environmentally friendly• Smart Treats

– Guilt-free delicious• Sensitivity Training

– Catering to food allergies, intolerances

• Vitality Treadmill– 5Ks to 40 winks (energy

management)• New Venues

– Restaurants, C-stores, vending

Sloan Trends 2008Presented at SupplySideEast, April 29, 2008 25

Nutritional Immunology• Caloric Restriction (25-40%) [animal models]

– Prolongs life span– Inhibits age-related diseases– Prevents obesity and hyperglycemia– Increases antioxidant enzymes and DNA repair

processes– Modulates immune function and alters gene

expression– Decreases insulin resistance

Fernandes G. Immunol Res 2008;40(3):244-6126

Nutritional Immunology• Caloric Restriction + Omega-3s [animal

models] Th-1/Th-2 cytokines adhesion molecules COX-2/PGE2 levels pro-inflammatory cytokines (e.g., IL-1, IL-6,

and TNF-) NF-B and AP-1 activity body weight and insulin sensitivity

Fernandes G. Immunol Res 2008;40(3):244-61

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Favorite New Immune Products

“Let nothing which can be treated by diet be treated by other means.”

- Maimonides

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Favorite New Immune Products

http://www.emergewater.com/products.asp

Manufacturer/Brand:

Cott Beverages

Relevant Ingredient(s): Immunity, with vitamin C and zinc to boost immune system, promote general health and well being; Protect, in Pomegranate, Açai, Blueberry, with powerful antioxidants to defend cells against damage caused by free radicals

Marketing/Positioning:“Emerge into a better life”

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Favorite New Immune Products

http://www.frutzzo.com/

Manufacturer/Brand:

Frutzzo, LLC

Marketing/Positioning:“Natural healing defense in a bottle,” protects against degenerative diseases and premature aging, boosts immunesystem;

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Ingredients: Yumberry, organic apple juices from concentrates and natural flavors.

Favorite New Immune Products

http://www.nakedjuice.com/

Relevant Ingredient(s): probiotics (Bifidobacterium) and prebiotics

Marketing/Positioning:Aids in digestive and immune health

Manufacturer/Brand: Naked Juice Co., a subsidiary of PepsiCo

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Product LabelsWhere’s the Immune Component?

32http://www.nakedjuice.com/http://www.frutzzo.com/http://www.emergewater.com

/products.asp

Favorite New Immune Products

Immune Health Basics with Wellmune WGP

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http://www.wellmune.com/

Favorite New Immune Products

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Mia Relax with Wellmune WGPDean Foods/White Wave -- Test market in Colorado

250 mg Wellmune/240 mL

Summary

• Immune health has reached critical mass among consumers.

• Tremendous growth of products boasting immune benefits.

• Look for solid research demonstrating safety and efficacy.

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“The doctor of the future will give no medication, but will interest his

patients in the care of the human frame, diet and in the cause and

prevention of disease.” - Thomas Edison

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