Clinical Data Update.
Prepared by Biothera, manufacturers of Wellmune WGP®
Biothera is involved in a multi-year clinical program to evaluate the efficacy of Wellmune WGP® in humans under various physical and psychological stress situations. To date, years of research has resulted in a product with a well-defined mechanism of action, a compelling body of credible, peer-reviewed science and increasing clinical evidence of its efficacy.
Clinical studies completed in the past 3 years were designed to assess the impact of Wellmune WGP on the physical and psychological health of individuals experiencing lifestyle and physical stress that often directly lead to illness. The studies featured members of the general population including firefighters, marathoners, students and individuals with moderate to high lifestyle stress.
A summary of the clinical data is presented here for review. The complete body of research supporting Wellmune WGP includes additional clinical research, numerous preclinical studies and human biomarker research. Biothera remains committed to ongoing research that advances the science of its ingredients and understanding of immune health.
Human clinical studies
Biothera’s clinical research demonstrates that Wellmune WGP taken orally improves the health of human subjects. The trials were designed to determine if immune enhancement demonstrated in vitro with Wellmune WGP would result in a reduction in the severity and duration of upper respiratory tract infection (URTI) symptoms in normal as well as stressed populations. Two of the studies also evaluated if Wellmune WGP would improve how “well” subjects felt (documented via Profile of Mood States). The following data summarizes data clinical trials conducted with Wellmune WGP. As expected all of the studies demonstrate that Wellmune WGP can reduce the duration and severity of upper respiratory tract symptoms in both healthy individuals as well stressed subjects.
In a cold season study published by Feldman et al (1) that involved 40 healthy subjects, Wellmune WGP reduced the incidence of fever and eliminated the need to miss work or school due to cold-like symptoms. The double-blind, placebo-controlled study included subjects, aged18-65, who were treated daily with either 500mg of Wellmune WGP or a placebo for 90 days. In contrast with the placebo group, the Wellmune WGP group reported an increase in general health markers, including physical energy and emotional well-being, as measured by a clinically validated health survey questionnaire (SF-36v-2). The study results were published in the Journal of Applied Research in 2009.
Lifestyle stress can take a toll, even on healthy individuals. A randomized, placebo-controlled, double blind design study was conducted to evaluate the effect of Wellmune WGP on symptoms associated with URTI symptoms and psychological well-being during periods of increased lifestyle stress (2). Moderate to highly stressed subjects (45 men, 105 women) ranging in age from 18–65 (mean age: 39 ± 11 years) were administered placebo, 250 mg, or 500 mg of Wellmune WGP during a 4 week treatment period. Subjects in both treatment groups (250 mg and 500 mg β-1,3/1,6 glucan per day) reported fewer upper respiratory tract infection symptoms, better overall health and increased vigor, and decreased tension, fatigue, and confusion based on the profile of mood states assessment.
Extreme physical stress often leads to increased challenges to the immune system; an example of extreme physical stress is running a marathon. A placebo-controlled, double-blind study was designed to evaluate the effect of Wellmune WGP on upper-respiratory tract symptoms (URTI) and mood state in marathon runners (3). Seventy-five marathon runners (35 men, 40 women) ranging in age from 18–53 years, mean age: 36 ± 9, self-administered placebo, 250 mg or 500 mg of Wellmune WGP® daily during the 4 week post-marathon trial period following the 2007 Carlsbad Marathon. Subjects filled out the profile of mood state (POMS) assessment and a questionnaire style health log measuring health status and URTI symptoms after 2- and 4-week treatment administrations. During the course of the 4-week study, subjects in the treatment groups (250 mg and 500 mg Wellmune WGP per day) reported significantly fewer URTI symptoms, better overall health and decreased confusion, fatigue, tension, and anger, and increased vigor based on the POMS survey compared to placebo. The authors concluded that Wellmune WGP may reduce URTI symptoms, and improve overall health and mood following a competitive marathon.
A study conducted by the University of Montana (4), with funding from Biothera and the U.S. Air Force, found that wildland firefighters benefited from Wellmune WGP. The results were presented at the American College of Sports Medicine in May 2008. In a double-blind, random cross-over design subjects completed two 14-day conditions with a three day washout between trials.
Supplements were consumed once a day and consisted of Immune Health Basics and a similar capsule placebo. In comparison with the control group, Wellmune WGP subjects experienced a 23% reduction in upper respiratory tract infection symptoms and a dramatic improvement in overall physical health. Subjects completed a daily health questionnaire as used by Nieman et al. (2002), with additional questions added that pertained specifically to use of the Wellmune WGP supplement. An individual was classified as having an URTI when they recorded a cold or flu symptom for a minimum of two consecutive days. At the conclusion of each trial subjects completed an overall health performance questionnaire, which contained questions regarding subjects overall health during the 14-day trial.
Several studies show a suppression of both immune system function and mood state following psychological stress. Previous research has demonstrated that Wellmune WGP is effective in reducing the incidence of URTI symptoms. In this lifestyle stress study, presented at the 2010 Experimental Biology meeting (5), the authors evaluated the effect of Wellmune on upper respiratory tract infections (URTIs) and psychological well-being.
One hundred twenty-two healthy subjects (32 men, 90 women, 38 ± 12 years) pre-screened for moderate levels of psychological stress, self-administered a placebo or 250mg of Wellmune daily for 12-weeks. The Profile of Mood States (POMS) psychological survey was used to assess for changes in mental/physical energy levels (Vigor) and overall well-being (Global Mood State). A quantitative health perception log was used to tract URTI symptoms. Subjects in the treatment group reported fewer URTI symptoms compared to Placebo, better overall well-being and superior mental/physical energy levels. These data show that daily dietary supplementation with Wellmune reduces URTI symptoms and improves mood state in stressed subjects, and thus may be a useful approach for maintaining immune protection against daily stressors.
The most recent studied completed with Wellmune WGP involved 100 4th year medical students as Southampton University in the U.K. Students took either Wellmune WGP (250 mg) or a placebo (250 mg of rice flour) for 90 days in a randomized, double-blind, placebo-controlled study (6). Students were evaluated for URTI symptoms (frequency and duration), POMS and immune blood biomarkers. The data and report are still being prepared, but preliminary data showed a significant reduction in the number of days that subjects experience URTI symptoms when taking Wellmune WGP vs. a placebo.
Wellmune WGP is a GRAS food ingredient which can enhance the ability of the immune system to fight off foreign challenges. There is an extensive body of published, peer reviewed science which has demonstrated the safety, mechanism of action and effectiveness of Wellmune WGP in shortening the duration and severity of upper respiratory tract symptoms in both well and stressed subjects. Biothera is committed to continuing to conduct and publish additional clinical trials with Wellmune WGP.
1. Feldman, S., H. I. Schwartz, D. S. Kalman, A. Mayers, H. M. Kohrman, R. Clemens and D. R. Krieger. 2009. Randomized phase II clinical trials of Wellmune WGP® for immune support during cold and flu season. J. Appl. Res. Clin. Expt. Ther. 9:30-42. 2. Talbott, S. and J. Talbott. 2010. Beta 1,3/1,6 Glucan Decreases Upper Respiratory Tract Infection Symptoms and Improves Psychological Well-Being in Moderate to Highly-Stressed Subjects. Agro Food Industry Hi-Tech. 21:21-24. 3. Talbott, S. and Talbott, J. 2009. Effect of BETA 1, 3/1, 6 GLUCAN on Upper Respiratory Tract Infection Symptoms and Mood State in Marathon Athletes. J. Sports Sci Med. 8:509-515. 4. Domitrovich, S. G.; Domitrovich, J. W.; Ruby, B. C. 2008. Effects of an immunomodulating supplement on upper respiratory tract infection symptoms in wildland firefighters. Medicine & Science in Sports & Exercise. 40(5):S353. 5. Talbott, S. and J. Talbott. 2010. Beta-Glucan Supplement Reduces URTIs (Upper Respiratory Tract Infections) and Improves Mood State in Healthy Stressed Subjects. FASEB J. 24:922.11. 6. Fuller, R. and Kenyon J. 2010. Wellmune WGP (1-3 1-6 Glucopolysaccharide)- A Randomised Controlled Trial. Unpublished data.