Resveratrol and Cardiovascular Health in the Elderly

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01842399
First received: April 25, 2013
Last updated: June 6, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention Phase
Vascular Resistance
Aging
Hypertension
Antioxidants
Aerobic Capacity
Dietary Supplement: Resveratrol
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Decreased rate of age associated arterial stiffening [ Time Frame: Week 16, 32, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in aerobic capacity, functional capacity, body composition, muscle energetics, inflammatory markers, glucose metabolism. [ Time Frame: Week 16, 32, 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Experimental 1
2x/day orally
Drug: Placebo
2x/day orally
Experimental: Experimental 2
75 mg, 2x/day, orally
Dietary Supplement: Resveratrol
Dietary Supplement
Experimental: Experimental 3
150 mg, 2x/day, orally
Dietary Supplement: Resveratrol
Dietary Supplement

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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

Females must be postmenopausal (no menses within 12 months).

EXCLUSION CRITERIA:

BMI less than 25 or greater than 35.

Diabetic subjects by history, Hemoglobin A1C greater than 6.5, or random serum glucose greater than 200 mg/dl.

Renal dysfunction (GFR less than 60 mL/min).

Medications:

Cholesterol medications Atorvastatin(Lipitor) Rosuvastatin (Crestor), Simvastatin (Zocor), Gemfibrazole (Lopid), Niacin (Niacor), etc.

Aspirin

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, pacemaker, etc.

Smoking nicotine presently or within the last 3 months.

Known congestive heart failure now or in the past.

Premenopausal women (menses within 12 months).

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 HIV or Hepatitis testing.

Positive urine drug test.

Positive urine pregnancy test.

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 provided informed consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842399

Contacts
Contact: Vickie L Schaffner (410) 350-7319 schaffnervl@mail.nih.gov
Contact: Luigi Ferrucci, M.D. (410) 558-8110 ferruccilu@grc.nia.nih.gov

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: NIA Studies Recruitment    410-350-3941    niastudiesrecruitment@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Luigi Ferrucci, M.D. National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01842399     History of Changes
Other Study ID Numbers: 999913078, 13-AG-N078
Study First Received: April 25, 2013
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Vascular Stiffness
Aging
Resveratrol
Aerobic Capacity
Inflammation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014