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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Calorie Restriction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resveratrol | Dietary Supplement | one pill of resveratrol (Resvida™) 75 mg once a day with breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| global skeletal muscle gene expression profile | three months |
| Measure | Description | Time Frame |
|---|---|---|
| insulin sensitivity | three months | |
| intrahepatic triglyceride content, body composition | three months | |
| blood lipid levels, markers of inflammation and plasma hormones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| placebo | Other | one placebo pill taken once a day with breakfast |
|
| Calorie Restriction | Behavioral | supervised calorie restriction diet: 30% reduction in caloric intake |
|
| three months |
| safety and tolerability | three months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |