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

National Research Council, Spain150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Cardiovascular Diseases

Interventions

Resveratrol-enriched grape extract in PPDIETARY_SUPPLEMENT

Resveratrol-enriched grape extract (Stilvid) is obtained from grapes treated with UVC illumination. Similar polyphenolic content to conventional grape extract used in the arms 'Grape extract in PP' and 'Grape extract in SP' but containing 8 mg resveratrol. 12 months follow-up: 1. capsule/day (350 mg resveratrol-enriched grape extract) for 6 months 2. capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months

Resveratrol-enriched grape extract in SPDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Apolipoprotein-B

Time frame: 6 months

oxidized LDL particles

Time frame: 6 months

Plasminogen activator inhibitor type 1 (PAI-1)