Effect of Resvida, a Comparison With Calorie Restriction Regimen (Resvida)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes; Metabolic Syndrome; Aging
• Intervention / Treatment: Dietary supplement: resveratrol; Other: placebo; Behavioral: Calorie Restriction

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: placebo; one placebo pill taken once a day with breakfast
Experimental: Resveratrol	Dietary supplement: resveratrol; one pill of resveratrol (Resvida™) 75 mg once a day with breakfast; Other Names: Resvida™
Active Comparator: Calorie Restriction	Behavioral: Calorie Restriction; supervised calorie restriction diet: 30% reduction in caloric intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
global skeletal muscle gene expression profile	three months

Secondary Outcome Measures

Outcome Measure	Time Frame
insulin sensitivity	three months
intrahepatic triglyceride content, body composition	three months
blood lipid levels, markers of inflammation and plasma hormones	three months
safety and tolerability	three months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: DSM Nutritional Products, Inc.
• Investigators: Principal Investigator: Samuel Klein, M.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: diabetes; obesity; aging; metabolic syndrome; antioxidant; resveratrol; calorie restriction
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 2007-09-25-RESV