Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

NCT ID: NCT01354977

Last Updated: 2022-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2017-09-15

Brief Summary

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Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.

Detailed Description

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Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.

Conditions

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Type 2 Diabetes Mellitus Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resveratrol

Each participant will receive a 28 days' supply of resveratrol capsules on day 0.

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

1,000mg twice daily for 28 days

Interventions

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Resveratrol

1,000mg twice daily for 28 days

Intervention Type DRUG

Other Intervention Names

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3,5,4'-trihydroxy-trans-stilbene

Eligibility Criteria

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Inclusion Criteria

* BMI: 26-35
* Non-smoker
* Normal screening labs (CMC, chemistry, LFTs PT/PTT)
* No CAD
* Good IV access

Exclusion Criteria

* High cholesterol
* \<4 week history of participation in another drug trial
* Severe hypertension
* Heart disease
* Liver disease of liver abnormalities
* Cerebrovascular disease, i.e. stroke
* CVD
* Seizures
* Bleeding disorders
* Muscle disease
* Cancer
* HIV
* Hepatitis (all types)
* Mentally disabled persons
* Pregnant women
* Allergies to Novocaine, Lidocaine, Benzocaine
* Subjects on the following medications:

* Anticoagulant and antiplatelet drugs
* Anti-epileptic drugs
* Mexiletene
* Quinidine
* Cyclosporine
* Tacrolimus
* HIV protease inhibitors
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Meredith Hawkins

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meredith A Hawkins, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2007-534

Identifier Type: -

Identifier Source: org_study_id

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