Effect of Resvida, a Comparison With Calorie Restriction Regimen (Resvida)
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.
|Obesity Metabolic Syndrome Diabetes Aging||Dietary Supplement: resveratrol Other: placebo Behavioral: Calorie Restriction|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen|
- global skeletal muscle gene expression profile [ Time Frame: three months ]
- insulin sensitivity [ Time Frame: three months ]
- intrahepatic triglyceride content, body composition [ Time Frame: three months ]
- blood lipid levels, markers of inflammation and plasma hormones [ Time Frame: three months ]
- safety and tolerability [ Time Frame: three months ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Dietary Supplement: resveratrol
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
Other Name: Resvida™
|Placebo Comparator: Placebo||
one placebo pill taken once a day with breakfast
|Active Comparator: Calorie Restriction||
Behavioral: Calorie Restriction
supervised calorie restriction diet: 30% reduction in caloric intake
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823381
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Samuel Klein, M.D.||Washington University School of Medicine|