Resveratrol and the Metabolic Syndrome

NCT01714102 | Completed

• 1 other identifier: JWA-0786
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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. Investigators 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.

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome

Keywords

Obesity; Insulin resistance; Metabolic syndrome; Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• Reduction in Insulin resistance

  Investigators anticipate resveratrol will have positive effect (ie reduction) on Insulin resistance as determined by Euglycemic hyperinsulinemic clamp

  Days 4-8 and Days 31-35

Secondary Outcomes (7)

• Reduction in serum cytokines/chemokines

  Days 4-8 and Days 31-35

• Reduction in blood pressure measurements

  Days 4-8 and Days 31-35

• Reduction lipid values

  Days 4-8 and Days 31-35

• Reduction in crown like structures and adipose tissue mass

  Days 4-8 and Days 31-35

• Changes in HOMA-IR

  Days 4-8 and Days 31-35

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for 30 days

Dietary Supplement: Resveratrol

Resveratrol

ACTIVE COMPARATOR

1000 mg PO BID for 30 days

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo manufactured to mimic resveratrol tablet

Resveratrol

Resveratrol DIETARY_SUPPLEMENT

Resveratrol PO BID for 30 days

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30 - 60 year old men
• Willingness to be randomized to resveratrol or placebo.
• BMI 30-40
• Evidence of insulin resistance with one of the following:
• hr oral glucose tolerance result =/\>120mg/dl at 2hrs acanthosis nigricans, or HgA1C 5.7 - 7.9%, or FBS \>/= 100 mg/dl AND at least 2 of the following: waist circumference \> 102 cm triglycerides \> 150 but \< 500 mg/dL HDL \< 40 mg/dL Pre- hypertension or hypertension: BP\>120/80 mmHg but \<150/90 mmHg
• Willingness to consume only study food and drink during the in-pt phases
• Willingness to avoid the use of over-the-counter medications, herbs, or supplements within the last 30 days.
• Willingness to avoid NSAIDS (advil, aleve, motrin, etc.) and aspirin for the entire study
• Willingness to avoid ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, and red wine throughout the entire study, including run-in period.
• Willingness to maintain weight for the duration of the study.
• Willingness not to start an exercise regime during study participation

You may not qualify if:

• Tobacco smoker any time within the last 3 months
• Bleeding disorder by history or by Bleeding Questionnaire results
• History, physical or EKG findings suggestive of CV disease including angina, MI, hx of med/surg tx of atherosclerotic heart disease, or congestive heart disease
• BP \> 145/90 after 10 minutes of rest on 2 or more screening visits
• Fasting glucose \> 165 mg/dL at screening
• HbA1C \> 8.0 at screening
• Current use of oral hypoglycemic agents
• Chronic glucocorticosteroid use or use of oral glucocorticosteroids for 5 days within the last year (inhaled glucocorticosteroid use may be acceptable; this will be determined by the PI)
• Current use of over the counter or prescription weight loss medication
• Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin).
• Hyperthyroidism or untreated hypothyroidism
• Obstructive sleep apnea, or significant symptoms suggestive of this condition.
• Current use of anticoagulants
• Known history of chronic hepatitis or liver enzymes (ALT or AST \> 2.5 times the normal upper limit)
• Known HIV infection or confirmed positive test for HIV antibodies at screening

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome; Glucose Intolerance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Jeanne Walker, MSN/NP-C

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Nurse Practitioner & Research Coordinator

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: July 1, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)