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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823381
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : December 10, 2013
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Diabetes Aging Dietary Supplement: resveratrol Other: placebo Behavioral: Calorie Restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. global skeletal muscle gene expression profile [ Time Frame: three months ]

Secondary Outcome Measures :
  1. insulin sensitivity [ Time Frame: three months ]
  2. intrahepatic triglyceride content, body composition [ Time Frame: three months ]
  3. blood lipid levels, markers of inflammation and plasma hormones [ Time Frame: three months ]
  4. safety and tolerability [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823381

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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.
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Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
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Responsible Party: Washington University School of Medicine Identifier: NCT00823381    
Other Study ID Numbers: 2007-09-25-RESV
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by Washington University School of Medicine:
metabolic syndrome
calorie restriction
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents