Biothera, the Minnesota-based manufacturer of immune system support ingredient Wellmune WGP, has cut another notch in the science quiver for the ingredient with the results of recent study in the UK. A trial conducted with 100 medical students found Wellmune significantly reduced the duration of upper respiratory tract infection (URTI) symptoms during the peak of the cold-flu season.
Biothera has an enviable track record of solid clinical results with Wellmune. In this most recent, 90-day study, medical students at Southampton University Medical School taking Wellmune WGP daily reported 43 fewer days of URTI (sore throat, stuffy or runny nose, and cough) symptoms than their classmates who received a placebo.
"Medical students working long hours in hospitals are placing tremendous stress on their immune systems," said Dr. Richard Fuller, M.D. of The Dove Clinic for Integrated Medicine and principal investigator for the study. "Wellmune WGP activates innate immune cells, the body’s first line of defense, which helped students become more resilient to health challenges."
In another recently-reported study, 77 women who were screened for moderate to high levels of psychological stress were divided into two groups and given either a placebo or 250 mg of Wellmune WGP daily for 12 weeks. Only 10 percent of the Wellmune group reported URTI symptoms compared with 29 percent for the control group.
That combines with previously conducted clinical studies involving marathon runners, wildland firefighters, women and other individuals with high lifestyle stress. To learn more about the product and its research, visit www.wellmune.com.
With results like these, does it become hard to communicate the ingredient’s full benefits without crossing regulatory boundaries?
"We try to be very careful in terms of marketing claims. We view it as a supplement and we try to follow DSHEA," said David Walsh, vice president of communications for Biothera.
It does call for careful study design, though, to skirt the issue of a disease-use endpoint. Hence the studies that start with healthy populations that face hurdles in terms of stress and the inevitable exposure to germs during the cold and flu season.
"If you have an immune product and you want to try to demonstrate efficacy, it has to be in the face of some kind of challenge," Walsh said.
Wellmune is GRAS for foods and beverages, and has been showing up in a wide variety of products. But whatever the product, Biothera is careful to control how the ingredient is used. In other words, pixie dusters need not apply.
"We do require a dosing of 2.5 mg per kilo of body weight," said Walsh.