Resveratrol and the Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Jeanne Walker, Rockefeller University
ClinicalTrials.gov Identifier:
NCT01714102
First received: October 16, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Insulin Resistance
Metabolic Syndrome
Dietary Supplement: Resveratrol
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Trans-Resveratrol (RSV) on Insulin Resistance, Inflammation, and the Metabolic Syndrome: A Placebo Controlled, Double-Blind Study.

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Reduction in Insulin resistance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Investigators anticipate resveratrol will have positive effect (ie reduction) on Insulin resistance as determined by Euglycemic hyperinsulinemic clamp


Secondary Outcome Measures:
  • Reduction in serum cytokines/chemokines [ Time Frame: collected within 4 weeks ] [ Designated as safety issue: No ]
    Investigators anticipate resveratrol will have positive effect (ie reduction) on Serum cytokines/chemokines: IL6, IL10, TNFalpha, hsCRP, leukocytes, PAI-1, fibrinogen, adiponectin, MCP-1,GLP-1, leptin, insulin, serum endotoxins

  • Reduction in blood pressure measurements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    24 hour systolic blood pressure measurements

  • Reduction lipid values [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Lipid values to be reviewed: cholesterol, LDL, HDL, TG

  • Reduction in crown like structures and adipose tissue mass [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Crown like structures in adipose tissue, and adipose tissue mass

  • Changes in HOMA-IR [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Changes in 2 hr oral glucose tolerance test HOMA-IR


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for 30 days
Dietary Supplement: Placebo
Placebo manufactures to mimic resveratrol tablet
Active Comparator: Resveratrol
1000 mg PO BID for 30 days
Dietary Supplement: Resveratrol
Subjects receive either Resveratrol or placebo PO BID for 30 days

Detailed Description:

The 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. In a systematic review of resveratrol research, the authors conclude that "in contrast to the lacking data of resveratrol in humans, the animal data are promising and indicate the need for further human clinical trials." 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.

The 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

    2 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

Exclusion Criteria:

  • 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
  • Inflammatory bowel disease
  • Active cancer (currently under treatment)
  • Other medical condition that may cause significant weight loss or gain
  • Chronic or acute renal disease
  • Seizure disorder
  • History of any psychiatric hospital admission within the last 2 years
  • History of schizophrenia, psychosis, or bipolar disease
  • History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, impact the subject's ability to successfully participate in the study.
  • Alcohol or drug abuse within the last 2 years
  • Any medications metabolized by cytochrome p450 3A4 (CYPA3A4) (see attachment of these medications as an appendix)
  • Any autoimmune disease (ie rheumatoid arthritis, systemic lupus erythematosis, psoriasis)
  • Physical condition requiring special diet (ie celiac disease)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714102

Contacts
Contact: Lauren Corregano 1-800-782-2737 rucares@rockefeller.edu

Locations
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Lauren Corregano    800-782-2737    rucares@rockefeller.edu   
Principal Investigator: Jeanne Walker, MSN/NP-C         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Jeanne Walker, MSN/NP-C The Rockefeller University
  More Information

No publications provided

Responsible Party: Jeanne Walker, Senior Clinical Nurse Practitioner & Research Coordinator, Rockefeller University
ClinicalTrials.gov Identifier: NCT01714102     History of Changes
Other Study ID Numbers: JWA-0786
Study First Received: October 16, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Obesity
Insulin resistance
Metabolic syndrome
Pre-diabetes

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 20, 2014