Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance

NCT01375959 | Completed Results

• 1 other identifier: 2010-398
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Keywords

resveratrol; glucose intolerance; insulin resistance; endothelial function

Outcome Measures

Primary Outcomes (1)

• Post Meal Glucose Area Under the Curve

  Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.

  end of each of two 6 week treatment periods

Secondary Outcomes (1)

• Insulin Sensitivity Using a Modification of the Matsuda Index

  end of each of two 6 week treatment periods

Other Outcomes (3)

• Insulin Secretion

  end of each of two 6 week treatment periods

• Peripheral Microvascular Endothelial Function Via Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) Index

  end of each of two 6 week treatment periods

• Number of Differentially Expressed Transcripts

  end of each of two 6 week treatment periods

Study Arms (2)

Resveratrol

EXPERIMENTAL

resveratrol 500 mg capsules, 3 each day for 6 weeks

Dietary Supplement: resveratrol

Placebo

PLACEBO COMPARATOR

matching placebo capsule containing lactose, 3 each day for 6 weeks

Drug: Placebo

Interventions

resveratrol DIETARY_SUPPLEMENT

resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks

Also known as: RevGenetics, X500 Resveratrol

Resveratrol

Placebo DRUG

3 placebo capsules orally twice a day for 6 weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• impaired glucose tolerance

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• American Diabetes Association: collaborator

Study Sites (1)

Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jill Crandall
• Organization: Albert Einstein College of Medicine

jill.crandall@einstein.yu.edu

718-430-3765

Study Officials

• Jill Crandall, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: June 20, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: October 26, 2022
• Results First Posted: August 26, 2020

Record last verified: 2022-09

Locations

US (1)