Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial

Who is this study for? Participants aged 50 years or older
What treatments are being studied? Resveratrol
Status: Terminated
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

⁃ Male or Female, age 50 years or older

⁃ BMI greater than or equal to 25 or less than or equal to 35 and weight less than 300 pounds.

⁃ Participants must provide their own consent.

⁃ Females must be menopausal or have had a bilateral oophorectomy.

• If over 55 years old: no menses for 12 months or longer. Women over 55 years old who haven't had a period for a year will be considered menopausal and do not need a FSH test.

• If 50-55 years old: no menses for 12 months AND an FSH level greater than or equal to 20. Women between 50 and 55 years old who haven't had a period for a year, will need FSH test. If their FSH test is more than 20, they will be considered menopausal. If their FSH test is less than 20, they will not be eligible to participate.

Locations
United States
Maryland
National Institute of Aging, Clinical Research Unit
Baltimore
Time Frame
Start Date: 2015-07-14
Completion Date: 2022-12-21
Participants
Target number of participants: 73
Treatments
Placebo_comparator: Placebo Comparator
2x/day orally
Experimental: Resveratrol 1
75 mg, 2x/day orally
Experimental: Resveratrol 2
150 mg, 2x/day orally
Related Therapeutic Areas
Sponsors
Leads: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov

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