Resveratrol and Cardiovascular Health in the Elderly

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Vascular Resistance, Hypertension

In brief

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.

Key facts

Study ID

NCT01842399

Run by

National Institute on Aging (NIA)

People needed

73

Starts

2015-07-14

Expected to finish

2022-12-21

Last updated by the study team

2022-12-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Liver Function Tests (LFT) greater than 2 times normal.
• Abnormal thyroid function, as evidenced by Free T3, t4, Free T4 or TSH +/- 5% of the lab reference ranges
• History of diabetes (gestational diabetes ok).
• Hemoglobin A1C greater than 6.5 and/or fasating serum glucose greater than or equal to 126 mg/dL.
• Renal dysfunction (GFR less than 60 mL/min).
• Abnormal Coagulation profile (PT/PTT and INR).
• Medications: (Due to potential interaction with resveratrol)
• Cholesterol medications Atorvastatin(Lipitor) Rosuvastatin (Crestor), Simvastatin (Zocor), Gemfibrazole (Lopid), Niacin (Niacor), etc.
• Aspirin greater than 81 mg
• Taking medicines that may increase the risk of bleeding such as Coumadin (warfarin), Plavix (clopidogrel), Xarelto (rivaroxaban), Pradaxa (dabgatran), Eliquis (apixaban) or Heparin (blood thinning medications) due to their potential interaction with resveratrol and the increased risk for bleeding with the muscle biopsy.
• Taking supplements such as Ginkgo biloba, Ginseng or Ginger due to their increased risk of bleeding with the muscle biopsy.
• Chronic (daily) use of non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen)-due to potential interaction with resveratrol. (Occasional use is ok if the participant does not take them 4 days before and 3 days after the muscle biopsy procedure).
• Anti-diabetic medications: Insulin, Metformin (Glucophage, Avandamet, Glibomet, etc), Rosiglitazone (Avandia), Exenatide (Byetta), Sitagliptin (Januvia), etc
• Testosterone and estrogen supplement
• Current glucocorticoid use, or up to 3 months ago (nasal, topical, ophthalmic, and inhaled use are not exclusionary)
• Vitamin supplements containing resveratrol
• Contraindications to MRI Study; e.g. metal implants, pacemakers, etc and hip replacements (metal or plastic) due to inhibiting visualization of the area being scanned.
• Smoking nicotine presently or within the last 3 months.
• Known congestive heart failure now or in the past.
• Alcohol consumption more than 30 grams (equivalent to about 10 ounces of wine; 24 ounces of beer; 3 ounces of hard liquor) for men or 15 grams for women (equivalent to about 5 ounces of wine; 12 ounces of beer; 1.5 ounces of hard liquor) daily.
• Positive screening result for alcohol use at the screening visit. Score 8+ on the AUDIT.
• Positive HIV, Hepatitis B or C testing.
• Positive urine drug test (exclusionary due to unknown interaction affect with study medication and question of compliance with study procedures).
• Benzodiazepines
• Amphetamines

Where it is running

• National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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