Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
Information source: National Research Council, Spain
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases
Intervention: 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 (Dietary Supplement)
Phase: Phase 2
Status: Completed
Sponsored by: National Research Council, Spain Official(s) and/or principal investigator(s): Juan Carlos EspĂn, PhD, Principal Investigator, Affiliation: National Research Council (CEBAS-CSIC, Murcia, Spain)
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Apolipoprotein-Boxidized LDL particles Plasminogen activator inhibitor type 1 (PAI-1) Adiponectin
Secondary outcome: C Reactive ProteinInterleukin-6 Interleukin-10 Interleukin-18 sICAM-1 sVCAM-1 D-dimer Fibrinogen Glycated hemoglobin Glucose GGT AST Urate ALT LDH TSH Thyroxine ALP CPK Bilirubin Creatinin Albumin Total cholesterol LDL-cholesterol HDL-cholesterol Triglycerides Hematocrit Hemoglobin Mean corpuscular volume Leucocytes Neutrophils Lymphocytes Eosinophils Platelets Mean platelet volume Sedimentation rate volume Gene expression profile in peripheral blood mononuclear cells (PBMNCs) Total homocystein levels Measurement of atheroma plaque and carotid intim thickness
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospital Morales Meseguer, Murcia 30008, Spain
Additional Information
Starting date: April 2009
Last updated: November 15, 2011
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