Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease

A Randomized, 12 Months Follow-up, Dose-response, Placebo-Controlled, Double-Blind, 6-Arms Parallel Trial to Evaluate the Safety and Efficacy of a Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Patients of Cardiovascular Disease

Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the cardioprotective role of resveratrol as part of the human diet is not yet clear.

The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention.

All the patients are gold-standard medicated (statins and others). A number of cardiovascular risk and safety markers will be evaluated after consuming 1 cap/day for 6 months and 2 caps/day for 6 additional months (total 12 months).

Inclusion Criteria:

FOR PRIMARY PREVENTION:

• Lack of known cardiovascular disease (coronary acute syndrome, stable ischemic cardiopathy, peripheric arteriopathy and cerebrovascular diseases).

• Age between 18 and 80 years.

• The above criteria and diabetes mellitus or at least two of the following risk factors:

  1. Active smoking (10 cigarettes or more per day).
  2. Arterial hypertension (>= 140/90 mmHg).
  3. Hypercholesterolemia (LDL-cholesterol >130 mg/dL and/or HDL-cholesterol < 45 mg/dL in women and 50 mg/dL in men).
  4. Obesity (BMI > 30 kg/m2)

FOR SECONDARY PREVENTION:

• Stable patients who coronary syndrome, cerebrovascular accident or peripheric arteriopathy event occurred at least 6 months or more before the recruitment in the study. In addition:

  1. Age between 18 and 80 years.

  2. Ejection fraction of left ventricle >=45%.

  3. Functional status I or II according to the New York Heart Association.

  4. Clinic stability in the recruitment (no symptoms of thoracic pain during the last month).

  5. Lack of residual lesions without vascularization in those patients with catheterism.

     Exclusion Criteria:

     FOR PRIMARY AND SECONDARY PREVENTION:

• Patients who do not satisfy inclusion criteria and:

  1. Known allergy to grapes
  2. Pregnancy or lactation
  3. Intake of nutraceuticals