Effect of Resvida, a Comparison With Calorie Restriction Regimen - Full Text View

Sponsor:	Washington University School of Medicine
Collaborator:	DSM Nutritional Products, Inc.
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00823381

Purpose

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.

Condition	Intervention
Obesity Metabolic Syndrome Diabetes Aging	Dietary Supplement: resveratrol Other: placebo Behavioral: Calorie Restriction

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Help Me Understand Genetics

MedlinePlus related topics: Antioxidants Diabetes Diabetes Medicines Dietary Supplements Metabolic Syndrome Obesity

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

global skeletal muscle gene expression profile [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

insulin sensitivity [ Time Frame: three months ] [ Designated as safety issue: No ]
intrahepatic triglyceride content, body composition [ Time Frame: three months ] [ Designated as safety issue: No ]
blood lipid levels, markers of inflammation and plasma hormones [ Time Frame: three months ] [ Designated as safety issue: No ]
safety and tolerability [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	January 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Resveratrol	Dietary Supplement: resveratrol one pill of resveratrol (Resvida™) 75 mg once a day with breakfast Other Name: Resvida™
Placebo Comparator: Placebo	Other: 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

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823381

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

DSM Nutritional Products, Inc.

Investigators

Principal Investigator:

Samuel Klein, M.D.

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Samuel Klein, MD, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00823381 History of Changes
Other Study ID Numbers:	2007-09-25-RESV
Study First Received:	January 13, 2009
Last Updated:	April 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

obesity
metabolic syndrome
diabetes
aging

calorie restriction
resveratrol
antioxidant

Additional relevant MeSH terms:

Diabetes Mellitus
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012