Clinical Trial Summaries > Green Tea and Weight Loss in Obese Individuals

July 2006

ProThera is pleased to report initiation of a new clinical trial for which it is providing administrative and technical support. Dr. Jennifer Donovan, a Research Assistant Professor at the Children’s Research Institute of the Medical University of South Carolina, has received approval and funding to conduct a clinical pilot study to evaluate the potential efficacy of green tea extract in promoting weight loss in overweight individuals. The approving Institutional Review Board (IRB) for the study is the Medical University of South Carolina Office of Research Integrity (MUSC ORI).

The pilot trial will be double-blind and placebo controlled. Dr. Donovan plans to enroll 36 otherwise healthy obese individuals and randomize them to receive green tea extract or placebo over an 18 week period. The objectives of the study are to assess if green tea extract promotes weight loss, changes resting metabolic rate and inhibits low-density lipoprotein (LDL) cholesterol oxidation. Dr. Donovan will collaborate with Dr. Feng Chen of Clemson University’s Department of Food Science and Human Nutrition, an expert on oxidative stress and LDL cholesterol. The pilot trial may generate the preliminary data needed to conduct more extensive clinical trials of green tea extract in the area of obesity, a condition that has increased dramatically in the United States affecting one third of adults and more than 15% of children.

ProThera is donating the green tea extract supplement custom-tailored to the study design and has also developed a placebo that matches the green tea extract in appearance and consistency. Stephen Olmstead, M.D., Chief Science Officer for ProThera, performed the block randomization and maintains the study blind. ProThera will also consult on analysis of the data upon completion of the study.