Obesity Clinical Trial
Official title:
Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen
The purpose of this study is to compare the effects of the antioxidant "resveratrol" to a
diet intervention (Calorie Restriction) to determine how each of them affects the following:
gene expression profile, cholesterol (lipids), how well the hormone insulin works to control
your blood sugar, and other blood and tissue markers of metabolic and cardiovascular health.
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have
health benefits such as improving fat metabolism, insulin action, and possibly extending
lifespan. Resvida™ is the name for the dietary supplement containing the natural antioxidant
"resveratrol". Resvida™ will be supplied by DSM Nutritional Products, Ltd.
Resvida™ is considered a dietary supplement, and therefore it is not an approved drug by the
Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
Administration does not strictly regulate herbs and dietary supplements. The makers of
Resvida™ make no claim that this supplement is meant to treat any ailment.
Calorie restriction (CR) is a low calorie diet (about 30% fewer calories than the American
Dietetic Association (ADA) recommends). Calorie restriction has also been linked to health
benefits (enhanced cardiovascular and metabolic health) and an extended lifespan.
This study is designed to compare the health benefits of both resveratrol and CR and to
determine if resveratrol mimics some of the health benefits shown with CR.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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