Abstract
Experimental Biology 2008
April 5-9, 2008
San Diego Convention Center
San Diego, California
A randomized, double-blind placebo controlled trial of Wellmune WGP® for immune support during cold season
Douglas Kalman, Ph.D., RD, FACN
Director, Phase I & Nutrition Business Development
Miami Research Associates
This 12-week, dual-center, parallel-group RDBT tested the safety and efficacy of a supplement Wellmune WGP® (Wellmune) in reducing the incidence, duration and severity of symptomatic respiratory illnesses (SRIs) in a healthy population during cold/flu season. The following data is from 1 of 2 sites. Study duration was 90 days and included evals by medical staff within 24 hours of cold onset. Of the 40 subjects enrolled at this site (18 to 65, at least 1 cold within the previous year), 33 were included in the intent-to-treat (ITT) and 27 in the per protocol (PP) populations. Although there were no differences in the incidence of SRIs, no subjects in the Wellmune group missed work or school due to colds while subjects with colds in the placebo group missed an average of 1.38 days; statistically significant via ITT and PP (0.00±0.00 vs 1.38±1.25; p=.026 and .042 respectively). The Wellmune group’s Physical Component Summary score (SF36v-2) improved significantly more than the placebo group after 90 days as compared to baseline per ITT (0.8±5.5 vs -1.9±2.8; p=0.042). The Wellmune group had a significantly lower average Fever score than the placebo group per PP (0.00±0.00 vs 3.50±3.42; p=0.042). Although there were no differences between the groups in the number of colds, Wellmune significantly reduced the days of missed school or work in a healthy population during cold season. There were no safety concerns. Funding source: Biothera.