Bronx, New York 10461


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.


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


Study is Available At:


Original ID:

2010-398


NCT ID:

NCT01375959


Secondary ID:


Study Acronym:

RSV


Brief Title:

Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance


Official Title:

The Effect of Resveratrol in Older Adults With Impaired Glucose Tolerance: a Double-Blind Crossover Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

50 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Albert Einstein College of Medicine of Yeshiva University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jill Crandall, MD
Principal Investigator
Albert Einstein College of Medicine of Yeshiva University
Primary Contact:Migdalia Reid, RN, MPH
718-405-8271
migdalia.reid@einstein.yu.edu

Study Dates

Start Date:April 2011
Completion Date:April 2014
Completion Type:Anticipated
Primary Completion Date:April 2014
Primary Completion Type:Anticipated
Verification Date:June 2011
Last Changed Date:June 16, 2011
First Received Date:May 12, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:post meal glucose area under the curve
Time Frame:end of each of two 6 week treatment periods
Safety Issues:False
Description:Glucose AUC following a standard mixed meal challenge
Outcome Type:Secondary Outcome
Measure:insulin sensitivity
Time Frame:end of each of two 6 week treatment periods
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:resveratrol
Description:resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
Arm Name:resveratrol
Other Name:RevGenetics
Intervention Type:Drug
Name:Placebo
Description:3 placebo capsules orally twice a day for 6 weeks
Arm Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:resveratrol
Study Arm Type:Placebo Comparator
Arm Name:placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Albert Einstein College of Medicine of Yeshiva University
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Diabetes Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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