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Randomized Phase II Clinical Trials of Wellmune® for Immune Support During Cold and Flu Season

Miami Research Associates

USC School of Pharmacy

Feldman S, Schwartz HI, Kalman DS, Mayers A, Kohrman HM, Clemens R, Krieger DR. (2009)

Journal of Applied Research 9:30-42

Abstract: 

Beta-glucan from oats and barley may decrease cardiovascular risk factors. Beta-glucan from some kinds of mushrooms may have as similar effect while modulating the immune system. This pilot trial examined whether beta-glucan derived from Saccharomyces cerevisiae can favorably decrease the risk of or symptomology associated with upper respiratory illness. Forty healthy adult subjects (18 to 65 years of age) were enrolled in a 12-week, randomized, double-blind, placebo-controlled, parallel-group trial conducted during the cold/flu season. The treatment arm compared Wellmune WGP® (WGP) gluco polysaccharide (beta-glucan) (500 mg/d) vs a placebo (500 mg rice flour). Cold/flu symptoms were evaluated by medical staff within 24 hours of onset. There were no significant differences in the incidence of symptomatic respiratory infections (SRIs) among the study groups. However, none of subjects in the WGP group missed work or school due to colds, while subjects with colds in the placebo group missed an average of 1.38 days (Intent to Treat: (0.00 ± 0.00 vs. 1.38 ± 1.25; p = 0.026). Quality of Life, assessed by the Physical Component Summary score (SF36v-2), improved significantly in the WPG group vs the placebo group after 90 days as compared to baseline (Intent to Treat: 0.8 ± 5.5 vs. -1.9 ± 2.8; p = 0.042). The WGP group had a significantly lower average fever score than the placebo group (Per Protocol: 0.00 ± 0.00 vs. 3.50 ± 3.42; p = 0.042). No adverse events were detected and no safety concerns were presented. This preliminary study suggests 1,3-1,6 beta-glucan from Saccharomyces cerevisiae may modulate the immune system and reduce some risks associated with upper respiratory influenza infections.

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