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

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ClinicalTrials.gov Identifier: NCT01375959
Recruitment Status : Unknown
Verified June 2011 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Recruiting
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Impaired Glucose Tolerance Dietary Supplement: resveratrol Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Resveratrol in Older Adults With Impaired Glucose Tolerance: a Double-Blind Crossover Study
Study Start Date : April 2011
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. post meal glucose area under the curve [ Time Frame: end of each of two 6 week treatment periods ]
    Glucose AUC following a standard mixed meal challenge


Secondary Outcome Measures :
  1. insulin sensitivity [ Time Frame: end of each of two 6 week treatment periods ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
American Diabetes Association
Investigators
Principal Investigator: Jill Crandall, MD Albert Einstein College of Medicine, Inc.
More Information

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
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by Albert Einstein College of Medicine, Inc.:
resveratrol
glucose intolerance
insulin resistance
endothelial function

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents