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Resveratrol and Cardiovascular Health in the Elderly

NCT01842399 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-12-23

No results posted yet for this study

Summary

Background:

\- Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it can have positive effects on human health. Lab studies show that it may help lower blood sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test different dose levels of Resveratrol to see what kind of effects it has on older overweight people. It will be tested in healthy volunteers at least 50 years of age.

Objectives:

\- To test the effects of different dose levels of Resveratrol on heart and blood vessel health.

Eligibility:

\- Healthy overweight nonsmoking volunteers at least 50 years of age.

Design:

* This study will involve a screening visit and four study visits. Some of the study visits will involve overnight inpatient stays.
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will be given a list of foods that they should avoid eating while on the study.
* Participants will be separated into three groups. Two groups will take different dose levels of the study drug. The third group will take a placebo.
* At the first study visit, participants will stay in the clinical center overnight for 2 days of tests. They will provide blood and urine samples and have body scans to measure fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be performed. At this visit, they will receive their dose of the study drug. They will continue to take this dose for as long as they are on the study.
* The second visit will be 16 weeks after the first one. It will take only 2 hours, and repeat most of the tests from the screening visit.
* The third visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the second visit will be repeated.
* The fourth and final visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the initial study visit (including the scans and the exercise tests) will be repeated.

Conditions

Interventions

DIETARY_SUPPLEMENT

Resveratrol

Nutriceutical

DRUG

Placebo

2x/day orally

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • Ajoy C Karikkineth, M.D. · National Institute on Aging (NIA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-14
Primary Completion
2020-07-31
Completion
2022-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842399 on ClinicalTrials.gov