Effect of Resvida, a Comparison With Calorie Restriction Regimen

Summary

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.

Conditions

• Obesity
• Metabolic Syndrome
• Diabetes
• Aging

Interventions

DIETARY_SUPPLEMENT

resveratrol

one pill of resveratrol (Resvida™) 75 mg once a day with breakfast

OTHER

placebo

one placebo pill taken once a day with breakfast

BEHAVIORAL

Calorie Restriction

supervised calorie restriction diet: 30% reduction in caloric intake

Sponsors & Collaborators

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Samuel Klein, M.D. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States

Study Locations