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Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial

Phase 1/Phase 2
50 Years
Open (Enrolling)
Vascular Resistance, Aging, Hypertension, Antioxidants, Aerobic Capacity

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Trial Information

Resveratrol and Cardiovascular Health in the Elderly: The Reache Trial

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.

Inclusion Criteria


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

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


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).


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Decreased rate of age associated arterial stiffening

Outcome Time Frame:

Week 16, 32, 52

Safety Issue:


Principal Investigator

James B Strait, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute on Aging (NIA)


United States: Federal Government

Study ID:




Start Date:

February 2013

Completion Date:

September 2015

Related Keywords:

  • Vascular Resistance
  • Aging
  • Hypertension
  • Antioxidants
  • Aerobic Capacity
  • Vascular Stiffness
  • Aging
  • Resveratrol
  • Aerobic Capacity
  • Inflammation
  • Hypertension



National Institute of Aging, Clinical Research UnitBaltimore, Maryland  21224