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.