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Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance (RSV)

This study is currently recruiting participants.
Verified June 2011 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01375959
First received: May 12, 2011
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
  Purpose

Resveratrol is a substance found in many plants, including grapes and red wine, which is widely used as a nutritional supplement. Studies in cells and lower animals show that resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and heart disease and normalization of glucose metabolism. Although use of this agent shows great promise in the treatment and/or prevention of diabetes, there have been no studies reported to date in humans. As an initial step, this proposal is for a 6 week pilot study of resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be conducted to explore how resveratrol works by studying cellular function (in muscle samples obtained from study participants) and by testing resveratrol's effect on blood vessel function.


Condition Intervention
Impaired Glucose Tolerance
 Dietary Supplement: resveratrol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Resveratrol in Older Adults With Impaired Glucose Tolerance: a Double-Blind Crossover Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • post meal glucose area under the curve [ Time Frame: end of each of two 6 week treatment periods ] [ Designated as safety issue: No ]
    Glucose AUC following a standard mixed meal challenge


Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: end of each of two 6 week treatment periods ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resveratrol Dietary Supplement: resveratrol
resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
Other Names:
  • RevGenetics
  • X500 Resveratrol
Placebo Comparator: placebo Drug: Placebo
3 placebo capsules orally twice a day for 6 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • impaired glucose tolerance

Exclusion Criteria:

  • history of estrogen-dependent neoplasm
  • use of certain drugs: high dose statins, warfarin, antiepileptics
  • current treatment with anti-diabetes medications
  • impaired liver or kidney function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375959

Contacts
Contact: Migdalia Reid, RN, MPH 718-405-8271 migdalia.reid@einstein.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University Recruiting
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
American Diabetes Association
Investigators
Principal Investigator: Jill Crandall, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Jill Crandall MD, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01375959     History of Changes
Other Study ID Numbers: 2010-398
Study First Received: May 12, 2011
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
resveratrol
glucose intolerance
insulin resistance
endothelial function

Additional relevant MeSH terms:
Resveratrol
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
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
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013