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

Primary Purpose

Obesity, Metabolic Syndrome, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
resveratrol
placebo
Calorie Restriction
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, metabolic syndrome, diabetes, aging, calorie restriction, resveratrol, antioxidant

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Resveratrol

Placebo

Calorie Restriction

Arm Description

Outcomes

Primary Outcome Measures

global skeletal muscle gene expression profile

Secondary Outcome Measures

insulin sensitivity
intrahepatic triglyceride content, body composition
blood lipid levels, markers of inflammation and plasma hormones
safety and tolerability

Full Information

First Posted
January 13, 2009
Last Updated
December 9, 2013
Sponsor
Washington University School of Medicine
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00823381
Brief Title
Effect of Resvida, a Comparison With Calorie Restriction Regimen
Acronym
Resvida
Official Title
Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Diabetes, Aging
Keywords
obesity, metabolic syndrome, diabetes, aging, calorie restriction, resveratrol, antioxidant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Calorie Restriction
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol
Other Intervention Name(s)
Resvida™
Intervention Description
one pill of resveratrol (Resvida™) 75 mg once a day with breakfast
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
one placebo pill taken once a day with breakfast
Intervention Type
Behavioral
Intervention Name(s)
Calorie Restriction
Intervention Description
supervised calorie restriction diet: 30% reduction in caloric intake
Primary Outcome Measure Information:
Title
global skeletal muscle gene expression profile
Time Frame
three months
Secondary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
three months
Title
intrahepatic triglyceride content, body composition
Time Frame
three months
Title
blood lipid levels, markers of inflammation and plasma hormones
Time Frame
three months
Title
safety and tolerability
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Effect of Resvida, a Comparison With Calorie Restriction Regimen

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