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

Phase 2

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Placebo in primary cardiovascular prevention (PP); Dietary Supplement: Placebo in secondary prevention; Dietary Supplement: Grape extract in primary prevention (PP); Dietary Supplement: Grape extract in SP; Dietary Supplement: Resveratrol-enriched grape extract in PP; Dietary Supplement: Resveratrol-enriched grape extract in SP

• Registration Number: NCT01449110
• Lead Sponsor: National Research Council, Spain

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-10
• Study Completion: 2011-03
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo in PP	Placebo in primary cardiovascular prevention (PP)	Placebo arm in primary cardiovascular prevention (PP)
Placebo in SP	Placebo in secondary prevention	Placebo arm in secondary cardiovascular prevention (SP)
Grape extract in PP	Grape extract in primary prevention (PP)	Grape extract obtained without resveratrol in primary cardiovascular prevention
Grape extract in SP	Grape extract in SP	Grape extract without resveratrol in secondary cardiovascular prevention
Resveratrol-enriched grape extract in PP	Resveratrol-enriched grape extract in PP	Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention
Resveratrol-enriched grape extract in SP	Resveratrol-enriched grape extract in SP	Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention

Primary Outcome Measures

Name	Time	Method
Apolipoprotein-B	6 months
oxidized LDL particles	6 months
Plasminogen activator inhibitor type 1 (PAI-1)	6 months and 12 months
Adiponectin	6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
C Reactive Protein	6 months 12 months
Interleukin-6	6 months and 12 months
Interleukin-10	6 months and 12 months
Interleukin-18	6 months and 12 months
sICAM-1	6 months and 12 months
sVCAM-1	6 months and 12 months
D-dimer	6 months and 12 months
Fibrinogen	6 months and 12 months
Glycated hemoglobin	6 months and 12 months
Glucose	6 months and 12 months
GGT	6 months and 12 months
AST	6 months and 12 months
Urate	6 months and 12 months
ALT	6 months and 12 months
LDH	6 months and 12 months
TSH	6 months and 12 months
Thyroxine	6 months and 12 months
ALP	6 months and 12 months
CPK	6 months and 12 months
Bilirubin	6 months and 12 months
Creatinin	6 months and 12 months
Albumin	6 months and 12 months
Total cholesterol	6 months and 12 months
LDL-cholesterol	6 months and 12 months
HDL-cholesterol	6 months and 12 months
Triglycerides	6 months and 12 months
Hematocrit	6 months and 12 months
Hemoglobin	6 months and 12 months
Mean corpuscular volume	6 months and 12 months
Leucocytes	6 months and 12 months
Neutrophils	6 months and 12 months
Lymphocytes	6 months and 12 months
Eosinophils	6 months and 12 months
Platelets	6 months and 12 months
Mean platelet volume	6 months and 12 months
Sedimentation rate volume	6 months and 12 months
Gene expression profile in peripheral blood mononuclear cells (PBMNCs)	6 months and 12 months	Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention.
Total homocystein levels	6 months and 12 months	Total homocystein levels in plasma evaluated with UPLC-MS-QqQ
Measurement of atheroma plaque and carotid intim thickness	12 months

Trial Locations

Locations (1)

University Hospital Morales Meseguer; 🇪🇸 Murcia, Spain