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Effect of Resvida, a Comparison With Calorie Restriction Regimen

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00823381
First received: January 13, 2009
Last updated: December 9, 2013
Last verified: December 2013

January 13, 2009
December 9, 2013
January 2009
December 2010   (final data collection date for primary outcome measure)
global skeletal muscle gene expression profile [ Time Frame: three months ] [ Designated as safety issue: No ]
global skeletal muscle gene expression profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823381 on ClinicalTrials.gov Archive Site
  • 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 ]
  • insulin sensitivity [ Time Frame: three months ] [ Designated as safety issue: No ]
  • cellular factors in muscle and adipose tissue involved in regulating inflammation and metabolic function [ Time Frame: three months ] [ Designated as safety issue: No ]
  • intrahepatic triglyceride content [ Time Frame: three months ] [ Designated as safety issue: No ]
  • blood lipid levels [ Time Frame: three months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Resvida, a Comparison With Calorie Restriction Regimen
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Obesity
  • Metabolic Syndrome
  • Diabetes
  • Aging
  • Dietary Supplement: resveratrol
    one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
    Other Name: Resvida™
  • Other: placebo
    one placebo pill taken once a day with breakfast
  • Behavioral: Calorie Restriction
    supervised calorie restriction diet: 30% reduction in caloric intake
  • Experimental: Resveratrol
    Intervention: Dietary Supplement: resveratrol
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
  • Active Comparator: Calorie Restriction
    Intervention: Behavioral: Calorie Restriction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Female
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823381
2007-09-25-RESV
Yes
Washington University School of Medicine
Washington University School of Medicine
DSM Nutritional Products, Inc.
Principal Investigator: Samuel Klein, M.D. Washington University School of Medicine
Washington University School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP