Effect of Resvida, a Comparison With Calorie Restriction Regimen

The Washington University

Status

Completed

Conditions

Aging

Diabetes

Obesity

Metabolic Syndrome

Treatments

Behavioral: Calorie Restriction

Other: placebo

Dietary Supplement: resveratrol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00823381

2007-09-25-RESV

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Post-menopausal females (at least 1 year since last spontaneous menstrual bleeding)
Caucasian
Weight (defined as BMI): ≥ 20kg/m2 and < 30 kg/m2.
Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements with specific agreement to a measurement of global gene expression profiles
Subjects with the ability to comprehend and complete forms in English
Subjects who are likely to comply with study procedures
Subjects who are willing to be assigned to the Resveratrol or CR or Placebo intervention

Exclusion criteria

History of serious or unstable medical or psychiatric disorders (e.g. diabetes, metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, musculoskeletal, or cancer) that, in the opinion of the investigator, would make the candidate ineligible for the study.
History of major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
Subjects with any allergic reaction or sensitivity to grape products or any component of the test article
Subjects who are allergic to lidocaine
Subjects currently on a low-calorie diet, a weight control or maintenance program, or those who practice a vegetarian or vegan diet
Subjects who engage in programmed exercise > 2 hours total per week
Subjects who are smoking or stopped smoking within the past 6 months
Subjects who have lost or gained >5 kg over the past six months
Subjects on any other clinical trial or experimental treatment within the past 3 months
Intake of dietary supplements except vitamins and minerals
Unwilling to restrict high resveratrol-containing foods
Current alcohol consumption >20 grams/day
Current use of the following medications: weight loss medications (prescription or over-the-counter), beta-blockers, steroids, anticoagulants, any other medications that, in the opinion of the investigator, may compromise the validity or safety of the study.