Effect of Resvida, a Comparison With Calorie Restriction Regimen

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Resvida(tm) Dietary Supplementation on Muscle Gene Expression: A Comparison With Calorie Restriction Regimen

Conditions
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Obesity, Metabolic Syndrome, Diabetes, Aging

Intervention / Treatment
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* Dietary Supplement: resveratrol
* Other: placebo
* Behavioral: Calorie Restriction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, metabolic syndrome, diabetes, aging, calorie restriction, resveratrol, antioxidant