Randomized Phase II Clinical T rials of W ellmune …

1 Randomized Phase II Clinical Trials of Wellmune WGP for Immune Support During Cold and Flu Season Samantha Feldman Howard I. Schwartz2. Douglas S. Kalman1. Athena Mayers1. Hannah M. Kohrman Roger Clemens3. Diane R. Krieger1. 1 Miami Research Associates, Department of Nutrition & Endocrinology, South Miami, FL 33143. 2 Miami Research Associates, Department of Gastroenterology, South Miami, FL 33143. 3 USC School of Pharmacy, Los Angeles, CA 90033. KEYWORDS: common cold, human symptoms were evaluated by medical influenza, beta-glucans staff within 24 hours of onset.

2 There were no significant differences in the incidence of symptomatic respiratory infections (SRI's) among the study ABSTRACT groups. However, none of subjects in Beta-glucan from oats and barley may the WGP group missed work or school decrease cardiovascular risk factors. due to colds, while subjects with colds in Beta-glucan from some kinds of mush- the placebo group missed an average of rooms may have as similar effect while days (Intent to Treat: ( modulating the immune system. This vs. ; p = ). Quality of pilot trial examined whether beta-glucan Life, assessed by the Physical derived from Saccharomyces cerevisiae Component Summary score (SF36v-2), can favorably decrease the risk of or improved significantly in the WPG.)

3 Symptomology associated with upper group vs the placebo group after 90 days respiratory illness. Forty healthy adult as compared to baseline (Intent to Treat: subjects (18 to 65 years of age) were vs. ; p = ). The enrolled in a 12-week, Randomized , dou- WGP group had a significantly lower ble-blind, placebo-controlled, parallel- average fever score than the placebo group trial conducted during the cold/flu group (Per Protocol: vs. season. The treatment arm compared ; p = ). No adverse events Wellmune WGP (WGP) gluco polysac- were detected and no safety concerns charide (beta-glucan) (500 mg/d) vs a were presented.

4 This preliminary study placebo (500 mg rice flour). Cold/flu suggests 1,3-1,6 beta-glucan from 30 Vol. 9, No. 1 & 2, 2009 The Journal of Applied Research Saccharomyces cerevisiae may modulate power, or lack of a Clinical effect. the immune system and reduce some Another possibility may be genetic vari- risks associated with upper respiratory ations and immunocompetencies among influenza infections. study subjects. Biological response modifiers such as INTRODUCTION beta-glucan, enhance the innate immune The common cold, typically caused by response without inducing damaging human parainfluenza viruses, remains pro-inflammatory cytokines, and may one of the most frustrating of medical represent a novel approach to protect illnesses, given its incidence and preva- against cold and flu pathogens.

5 37,38. lence. The common cold has significant Beta-glucans are glucose polymers effects on health, well-being, and pro- derived from yeast, fungi, or from oats. ductivity. Each cold experienced by a In vivo studies suggest beta-glucans may working adult results in an average of enhance the immune system responses lost work hours, and lost work to infectious organisms without eliciting hours due to attending to sick a pro-inflammatory cytokine response. The economic burden of lost productivi- 37,39-43. Other in vivo investigations report ty due to colds is approximately $25 bil- that oat-derived beta-glucan can lion annually, with lost productivity from decrease increased risk of upper respira- missed work days comprising the major- tory tract infection as a result of stress- ity of the financial There are ful exercise in ,45.

6 No reliable interventions currently avail- In Clinical trials, beta-glucan reduces able that significantly protect against postoperative infection rates and short- influenza infections or prevent the ens intensive care unit stay occurrence of this illness. There have One study also reported that increasing been several Clinical trials evaluating a doses of beta-glucan resulted in fewer variety of dietary supplements for the infections after prevention and treatment of both exper- Beta-glucan from a variety of dietary imentally induced and naturally occur- sources has immunomodulatory proper- ring colds.

7 Many of those interventions ties. The potential immunomodulatory included Echinacea,3-13 vitamin C,14-18 effect of beta-glucan from probiotics,19 ginseng,20 vitamin E, 21,22 and Saccharomyces cerevisiae has not been zinc. 20,23-36 Other studies indicate no evaluated in a structured Clinical trial dietary supplement consistently reduces that assesses its efficacy on the preven- the risk of the common cold. Some tion and/or treatment of the common studies suggest vitamin E and ginseng cold in a healthy adult population.

8 The may reduce the incidence of common current study aimed to determine colds,20,21 while other investigations whether the proprietary beta-glucan report no favorable effects of vitamin E extract Wellmune WGP (WGP) can on upper respiratory tract reduce the incidence and/or Zinc, from zinc acetate, is reported to duration/severity of respiratory illnesses reduce the symptom and severity of in a healthy population during peak common colds in healthy adults,29 while cold/flu season. other reports suggest the absence of any ,33 These apparent discrepancies MATERIALS AND METHODS.

9 Are due to various study limitations Protocol across the literature, such as potential A Randomized , double-blind, placebo- differences in product identity and dose, controlled, parallel-group trial compared and small sample size and low statistical beta-glucan extract Wellmune WGP . The Journal of Applied Research Vol. 9, No. 1 & 2, 2009 31. Table 1. Inclusion and Exclusion Criteria Criteria Inclusion criteria Age 18 and 65. Generally healthy BMI > 25 kg/m2 and 40 kg/m2 at screening Agree to all study visits and visit procedures Females must agree to use appropriate birth control methods during the study Community dwelling At least 1 self-reported cold in the last 12 months prior to screening Exclusion criteria Cigarette smoking Current respiratory illness Temperature > C at screening Immune modifying medications.

10 Anti-inflammatory agents, Antibiotics, Steroids Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following: AIDS, HIV, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST Syndrome, Crohn's Disease, Dermatomyositis, Fibromyalgia, Grave's Disease, Hashimoto's Thyroiditis, Lupus, Myasthenia Gravis, Pernicious Anemia, Polyarteritis Nodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud's Disease, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sj gren's Syndrome, Temporal Arthritis, Ulcerative Colitis, and Vitiligo Use of any immunosuppressive drugs in the last 5 years (Steroids, Biologics, etc.)