Apr 8, 2010

Posted by in Industry, Supplementation | 0 Comments

Clinical Studies for Dietary Supplements: An Interview with Dr. Darryn Willoughby

Darryn Willoughby

Dr. Willoughby holds BS and MEd degrees in Exercise Science from Tarleton State University and a PhD in Neuromuscular Physiology and Biochemistry with a sub-emphasis in Nutritional Biochemistry from Texas A&M University. He is a Fellow of the American College of Sports Medicine and the International Society of Sport Nutrition (ISSN). He is also the current President of the ISSN, and is a Certified Strength and Conditioning Specialist from the National Strength and Conditioning Association (NSCA) and a certified exercise and sport nutritionist from the ISSN.


RC: What is your title and what kind of research and studies do you conduct at Baylor University?

DW: I am a tenured, associate professor of exercise/nutritional biochemistry and molecular physiology in the department of health, human performance, and recreation. I conduct studies investigating the impact of resistance exercise, with or without nutritional intervention, on skeletal muscle growth by studying the expression behavior of various genes critical to muscle growth.

RC: Describe some of the studies you’ve conducted at Baylor, and your findings.

DW: I have done many studies involving some of the most popular sports nutrition products. My studies involving the aromatase inhibiting dietary supplements Novedex XT and 6-OXO showed that both of these supplements were effective at elevating endogenous levels of testosterone. I did a study involving a dietary supplement protein product where we found that supplementing with whey and casein protein combined with additional amino acids during resistance training was more effective at improving muscle strength, mass, and other training adaptations than training with carbohydrate supplementation alone. I have done studies on the functional thermogenic coffee JavaFit and showed it to be more effective than regular coffee at increasing resting energy expenditure and anaerobic exercise performance. I have done a study on the thermogenic supplement Meltdown and showed that it was effective at increasing resting energy expenditure and fat oxidation. I have done a study with the supplement product NO-Shotgun and showed that when combined with resistance training it was more effective at increasing muscle strength, mass, and markers of myogenesis than resistance training alone. I have done a study with creatine ethyl ester and showed that seven weeks of supplementation in conjunction with resistance training was not more effective than creatine monohydrate at increasing muscle creatine uptake or muscle strength and mass, however, it was shown to degrade into creatinine in circulation to a much greater extent than creatine monohydrate.

RC: What role do clinical studies generally play in the dietary supplement industry?

DW: Valid, clinically-controlled studies involving nutritional supplements are critical because the industry is not, or rather is poorly, regulated relative to manufacturer’s ability to substantiate their products’ claims and efficacy. These studies help shed light on alleged effectiveness, safety, etc. along with possible mechanisms of action of which a supplement is claimed to operate.

Baylor University

RC: What sets Baylor University apart from other research facilities and why do so many sports nutrition and dietary supplement companies choose Baylor to conduct their clinical studies?

DW: What sets Baylor apart is our laboratories and equipment, along with the wealth of knowledge and expertise of key faculty members. Our quality research efforts and the publications that have been produced as a result, speak for themselves. Companies choose Baylor for this reason, along with it being a major research university. In addition, companies know that the studies will get done in a timely fashion with a very meticulous and controlled approach.

RC: How does a company go about hiring you and Baylor University to design, conduct and publish a clinical study?

DW: They will need to contact me and discuss what it is they have in mind relative to the supplement and the purpose/goals of the project. I must have an active role in designing the study and making sure the study is appropriately controlled, and is not biased. I will then develop a proposal with a budget. Once we have come to an agreement relative to the parameters of the study, the time frame, and the budget, then I move forward and seek the appropriate permission for the university. Baylor and the sponsor will execute a clinical research agreement that gives me as the investigator some rights to the data, relative to publishing or presenting. Once the study is completed, a final report is provided to the sponsor. Prior to publishing or presenting, the sponsor will need to provide their permission for me to do so.

RC: Darryn, on behalf of my firm I would like to thank you for your time. We hope this interview will inspire more dietary supplement companies to arrange clinical studies for their supplement products.

Dr. Willoughby is an internationally recognized scholar and one of the top leaders in the field where his primary research focuses on the molecular mechanisms regulating muscle hypertrophy and atrophy and the efficacy of nutritional supplements. He can be reached by phone at his office at (254) 710-3504 or by email atDarryn_Willoughby@baylor.edu.

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