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Resveratrol and Cardiovascular Health in the Elderly

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 7, 2016 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ) Identifier:
First received: April 25, 2013
Last updated: April 20, 2017
Last verified: December 7, 2016

April 25, 2013
April 20, 2017
February 9, 2013
September 1, 2018   (Final data collection date for primary outcome measure)
Decreased rate of age associated arterial stiffening [ Time Frame: Week 16, 32, 52 ]
Same as current
Complete list of historical versions of study NCT01842399 on Archive Site
Changes in aerobic capacity, functional capacity, body composition, muscle energetics, inflammatory markers, glucose metabolism. [ Time Frame: Week 16, 32, 52 ]
Same as current
Not Provided
Not Provided
Resveratrol and Cardiovascular Health in the Elderly
Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial


- 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.


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


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


  • 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.

Resveratrol is found in the leaves and skin of grapes, in peanuts and in the roots of the plant polygonum cupsidatum. Although used since early years in Indian Ayurvedic and Chinese medicine, it came into prominence in the 1990 s as it was believed to be the major reason for the positive effect of wine on cardiovascular health and the French Paradox. Since then, studies have shown that resveratrol affects a number of key cellular pathways and molecular targets with a wide range of biological effects. Noted among these are its effects on the blood vessels, cancer, blood clotting, blood sugar control, muscle activity and inflammation. Resveratrol also may produce some of the same effects as decreased food intake, perhaps through its action on a molecule in the body called Sirtuin, which is important because this is one of the only approaches that has consistently demonstrated beneficial effects on the aging process.

Resveratrol s action and pharmacology has been extensively studied in test tubes, cells, and animals but is only now being explored fully in people. The animal studies include a recent NIA-conducted study in monkeys that demonstrated a reduction in the stiffness of blood vessel over several weeks. Phase 1 and 2 clinical studies in healthy human volunteers or in patients with type II diabetes mellitus have begun to identify possible roles for resveratrol as a nutritional supplement and the compound appears to have no harmful effects at doses up to 5 grams per day.

We will perform a 12-month, Phase 1/2 trial of resVida (an oral preparation of resveratrol) in 90 overweight/obese people over the age of 50 (30 in each group). The primary endpoint will be vascular stiffness (as measured by Pulse Wave Velocity) and the secondary endpoint will be exercise capacity as measured by oxygen utilization (VO2max). Testing will be done on the levels of resveratrol in the blood with different doses of the compound. The study will also include measurements of changes in blood glucose levels, inflammation, and exercise capacity. These studies will provide necessary information for further testing of resVida as a compound that could promote healthy aging.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Prevention
  • Vascular Resistance
  • Aging
  • Hypertension
  • Antioxidants
  • Aerobic Capacity
  • Dietary Supplement: Resveratrol
    Dietary Supplement
  • Drug: Placebo
    2x/day orally
  • Placebo Comparator: Experimental 1
    2x/day orally
    Intervention: Drug: Placebo
  • Experimental: Experimental 2
    75 mg, 2x/day, orally
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: Experimental 3
    150 mg, 2x/day, orally
    Intervention: Dietary Supplement: Resveratrol

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 1, 2018
September 1, 2018   (Final data collection date for primary outcome measure)

Male or Female, age 50 years or older, BMI 25-35.

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

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.


Liver Function Tests (LFT) greater than 2 times normal.

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

Anti-hypertensive medications Metoprolol (Lopressor), Carvedilol (Coreg), Nifedipine (Procardia, Adalat), Verapamil (Verelan,Calan, Covera), Lisinopril (Prinivil, Zestril), Captopril (Capoten), Losartan (Cozaar), Irbesartan (Avapro), 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 2.5 glasses of wine) for men or 15 grams for women (~1.5 glasses of wine) 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
  • Barbiturates
  • Cannabis
  • Cocaine

Receipt of any investigational products (e.g. drugs, supplements, dietary interventions) as part of a research study within 30 days of initial dose administration

Unable to comply with the study requirements and procedures.

Unable to perform treadmill testing due to reasons such as orthopedic problems, moderate to severe aortic stenosis as found on echocardiogram at ScreeningVisit, history of myocardial infarction in the last three months or angina (under treatment).

Unable to perform knee strength testing due to reasons such as bilateral knee replacements.

Unable to perform hand grip testing due to any limitation such as pain or deformity.

Allergy or intolerance to local anesthetic- Lidocaine.

Sexes Eligible for Study: All
50 Years to 100 Years   (Adult, Senior)
Contact: Denise L Melvin, R.N. (410) 350-3924
Contact: Luigi Ferrucci, M.D. (410) 558-8110
United States
Not Provided
Not Provided
Not Provided
Not Provided
National Institute on Aging (NIA)
National Institute on Aging (NIA)
Not Provided
Principal Investigator: Luigi Ferrucci, M.D. National Institute on Aging (NIA)
National Institutes of Health Clinical Center (CC)
December 7, 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP