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(JWA-0786) Resveratrol and the Metabolic Syndrome

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Pilot Study: The Effects of Trans-Resveratrol (RSV) on Insulin Resistance, Inflammation, and the Metabolic Syndrome: A Placebo Controlled, Double-Blind Study.

Principal Investigator:
Jeanne Walker ANP-C


Contact Information:
Recruitment Specialist
1230 York Avenue
New York, NY 10065
Telephone: 18007822737
Alt. Telephone: 18007822737
Enrollment Status:

Brief Summary of Protocol:
The metabolic syndrome is a combination of high blood sugar, high blood pressure, obesity, low HDL (good) cholesterol, high triglycerides, and excess fat around the abdomen. These abnormalities can increase your chances of having heart disease or diabetes. Dietary changes, physical activity, and weight loss are often recommended for people with the metabolic syndrome because they can lead to improvements in each of the abnormalities described above. However, people often re-gain weight and resume their usual life style. Resveratrol is a natural compound that comes from plants and is found in grapes, peanuts and red wine. Resveratrol has been shown in limited clinical studies and numerous animal studies to improve the components of the metabolic syndrome such as insulin resistance, high triglycerides and hypertension without weight loss. We are studying resveratrol to see if it can improve the health of people with the metabolic syndrome in a tightly controlled trial.

Detailed Description of Protocol:
Metabolic syndrome is a serious health condition that affects about 35 percent of adults and places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity, being overweight, physical inactivity and genetic factors. In recent decades, the prevalence has increased dramatically in the United States. Lifestyle interventions including dietary modification, physical activity and weight loss form the basis of treatment for these patients. However, research has shown that even when people are able to incorporate these changes, they often revert back to their usual lifestyle resulting in weight gain and continued risk for diabetes and heart disease. Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has been found to reverse some of the features of the metabolic syndrome (insulin resistance, high triglycerides, high blood pressure) in rodents. These improvements occurred without weight loss, and were proven to be a direct result of resveratrol ingestion. Other studies reveal improvement in cardiovascular health, tumor suppression, and longevity. However, there are few studies investigating these beneficial effects in humans.Of the small clinical studies that have been done, the results are encouraging. Improvement in triglycerides, blood pressure and insulin resistance were noted. Resveratrol was well tolerated without serious side effects. These studies, however, did not recruit subjects with the metabolic syndrome, nor were they tightly controlled. We propose to prove that resveratrol, administered to subjects with the metabolic syndrome, under controlled conditions of weight stability, common diet, and strict compliance with the study drug, will improve the symptoms of the metabolic syndrome, thereby decreasing the chance of developing diabetes or heart disease. It is evident that alternative treatment of people with the metabolic syndrome is essential to curb the rapid increase in adult onset diabetes, heart disease and stroke, resulting in premature disability and enormous health care costs.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. Age 30 - 60 year old men 2. BMI 30-40 3. Willingness to avoid the use of over-the-counter medications, herbs, or supplements within the last 30 days. 4. Willingness to avoid NSAIDS (advil, aleve, motrin, etc.) and aspirin for the entire study 5. Willingness to avoid ingestion of any foods containing peanuts, billberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, and red wine throughout the entire study, including run-in period. 6. Cannot be a current smoker 7. No history of cardiovascular disease 8. No current use of oral hypoglycemic agents 9. No current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin). 10. No sleep apnea 11. No known history of chronic hepatitis or HIV 12. Must be willing to stay at Rockefeller University for 35 days



Children permitted to participate:

Potential Benefits.....
Compensation is provided