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

Higher Council for Scientific Research (CSIC)

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Resveratrol-enriched grape extract in PP; Dietary Supplement: Grape extract in primary prevention (PP); Dietary Supplement: Resveratrol-enriched grape extract in SP; Dietary Supplement: Placebo in secondary prevention; Dietary Supplement: Placebo in primary cardiovascular prevention (PP); Dietary Supplement: Grape extract in SP

Study type: Interventional

Funder types: Other

Identifiers

NCT01449110

CEBAS-CSIC-1

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 6 patient groups, including a placebo group

Placebo in PP

Placebo Comparator group

Description:

Placebo arm in primary cardiovascular prevention (PP)

Treatment:

Dietary Supplement: Placebo in primary cardiovascular prevention (PP)

Placebo in SP

Placebo Comparator group

Description:

Placebo arm in secondary cardiovascular prevention (SP)

Treatment:

Dietary Supplement: Placebo in secondary prevention

Grape extract in PP

Active Comparator group

Description:

Grape extract obtained without resveratrol in primary cardiovascular prevention

Treatment:

Dietary Supplement: Grape extract in primary prevention (PP)

Grape extract in SP

Active Comparator group

Description:

Grape extract without resveratrol in secondary cardiovascular prevention

Treatment:

Dietary Supplement: Grape extract in SP

Resveratrol-enriched grape extract in PP

Experimental group

Description:

Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention

Treatment:

Dietary Supplement: Resveratrol-enriched grape extract in PP

Resveratrol-enriched grape extract in SP

Experimental group

Description:

Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention

Treatment:

Dietary Supplement: Resveratrol-enriched grape extract in SP