Using athletes as study subjects helps clear regulatory hurdles

05-Dec-2012 - Last updated on 05-Dec-2012 at 15:44 GMT

Related tags Dietary supplement Immune system Cancer

Working with athletes can provide a way to circumvent some of the challenges of dietary supplement research by offering up a ‘prestressed’ population, experts say.

The research of dietary supplement ingredients has always been complicated by the need to show an effect. If you have a joint health supplement, you conduct a trial with some osteoarthritis sufferers and see how they do, right? Or if you have a cardiovascular health ingredient, you could use as study subjects people who have already suffered a heart attack.

Such studies are conducted all the time, either sponsored by companies or performed by independent researchers. They provide very useful information on the mode of action of the various substances studied, but they don’t help much in the marketing of an individual ingredient because of the study design. Your ingredient treated osteoarthritis symptoms, or it helped prevent heart disease, or slowed the growth of certain cancerous tumors. In other words, the studies had disease end points, and yielded data the marketer of a dietary supplement can’t legally talk about, even if the manufacturer has strong evidence to show that that’s what the ingredient can do.

Proving a prophylactic effect is much trickier, and falls from a logical stand point into the realm of trying to prove a negative. It would generally require a bigger study population and therefore be more costly. How do you know how many people would have gotten sick but for the shielding effect of your ingredient?

But working with populations that are already stressed, such as athletes or medical studies, or even average subjects subjected to a stress such as a treadmill session, can yield useful data that also complies with regulatory restrictions.

Reproducible effects

Biothera, which has conducted an extensive series of human clinical trials and other studies on its flagship immune health ingredient Wellmune, has taken this approach. One of the big advantages is it puts the research program on a solid scientific footing, Don Cox, PhD, senior vice president of research and development told NutraIngredients-USA. The company has data from recreational athletes, marathon runners, and medical school students.

“I think with respect to athletes and medical students we are looking at a reproducible biological effect,” Cox said. “When you exercise subjects that are relatively fit there is reproducible medical effect on the immune system.”

A recent placebo-controlled study on Wellmune conducted at the University of Houston reproduced other results the company has obtained. After a 10-day supplementation period, the study subjects, a group of recreational athletes, rode an stationary bicycle in a heated room (100 degrees F) at 45% humidity. Blood drawn after the test measured various markers of immune system stress.

“In contrast to the placebo group, athletes taking Wellmune had a higher degree of immune support before and after exercise, as measured by monocyte concentrations and enhanced cytokine production during a simulated immune challenge,” said Brian McFarlin, Ph.D., Associate Professor of Exercise Physiology at the University of Houston.

Wellmune’s demonstrated support of the immune system in the face of challenges presented by exercise has caught the attention of pro sports organizations, the company said. Biothera executives recently presented information on the ingredient to coaches and trainers at Major League Baseball’s winter meetings which are underway in Nashville, TN. The response was enthusiastic, Cox said.

“There was significant interest You are talking people who are playing a sport for six to eight months. They are playing a very long, a very grueling season,” he said.

Sports nutrition innovation

It’s this combination of scientific reproducibility, regulatory compatibility and high interest in an ingredient’s possible prophylactic or even performance-boosting effects that makes the sports nutrition category a hotbed of innovation, said Brian Dixon, PhD, director of new product development at USANA Health Sciences.

“A lot of cutting edge advancements come out of that arena, whether its dosages, forms, even new ingredients. It comes out there first.

“In a way an extreme athlete, a professional athlete, is a compromised population, because they are always taking their bodies to the edge,” Dixon said.

“We have all these strategic partnerships with athletic organizations and a lot of them are interested in getting that competitive edge. So we conduct research with a few of these athletic teams that we partner with,” he said.