Clinical trial NCT01449110: Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Keywords: Primary prevention
Secondary prevention
Resveratrol
Grape
Cardiovascular
Nutraceutical
Food complement
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Hospital General Universitario Morales Meseguer
First posted: 2011-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Apolipoprotein-B
timeFrame: 6 months
measure: oxidized LDL particles
timeFrame: 6 months
measure: Plasminogen activator inhibitor type 1 (PAI-1)
timeFrame: 6 months and 12 months
measure: Adiponectin
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: C Reactive Protein
timeFrame: 6 months 12 months
measure: Interleukin-6
timeFrame: 6 months and 12 months
measure: Interleukin-10
timeFrame: 6 months and 12 months
measure: Interleukin-18
timeFrame: 6 months and 12 months
measure: sICAM-1
timeFrame: 6 months and 12 months
measure: sVCAM-1
timeFrame: 6 months and 12 months
measure: D-dimer
timeFrame: 6 months and 12 months
measure: Fibrinogen
timeFrame: 6 months and 12 months
measure: Glycated hemoglobin
timeFrame: 6 months and 12 months
measure: Glucose
timeFrame: 6 months and 12 months
measure: GGT
timeFrame: 6 months and 12 months
measure: AST
timeFrame: 6 months and 12 months
measure: Urate
timeFrame: 6 months and 12 months
measure: ALT
timeFrame: 6 months and 12 months
measure: LDH
timeFrame: 6 months and 12 months
measure: TSH
timeFrame: 6 months and 12 months
measure: Thyroxine
timeFrame: 6 months and 12 months
measure: ALP
timeFrame: 6 months and 12 months
measure: CPK
timeFrame: 6 months and 12 months
measure: Bilirubin
timeFrame: 6 months and 12 months
measure: Creatinin
timeFrame: 6 months and 12 months
measure: Albumin
timeFrame: 6 months and 12 months
measure: Total cholesterol
timeFrame: 6 months and 12 months
measure: LDL-cholesterol
timeFrame: 6 months and 12 months
measure: HDL-cholesterol
timeFrame: 6 months and 12 months
measure: Triglycerides
timeFrame: 6 months and 12 months
measure: Hematocrit
timeFrame: 6 months and 12 months
measure: Hemoglobin
timeFrame: 6 months and 12 months
measure: Mean corpuscular volume
timeFrame: 6 months and 12 months
measure: Leucocytes
timeFrame: 6 months and 12 months
measure: Neutrophils
timeFrame: 6 months and 12 months
measure: Lymphocytes
timeFrame: 6 months and 12 months
measure: Eosinophils
timeFrame: 6 months and 12 months
measure: Platelets
timeFrame: 6 months and 12 months
measure: Mean platelet volume
timeFrame: 6 months and 12 months
measure: Sedimentation rate volume
timeFrame: 6 months and 12 months
measure: Gene expression profile in peripheral blood mononuclear cells (PBMNCs)
timeFrame: 6 months and 12 months
measure: Total homocystein levels
timeFrame: 6 months and 12 months
measure: Measurement of atheroma plaque and carotid intim thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: University Hospital Morales Meseguer
Study officials:
affiliation: National Research Council (CEBAS-CSIC, Murcia, Spain)
name: Juan Carlos Espín, PhD
role: PRINCIPAL_INVESTIGATOR
References: