DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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-B

oxidized LDL particles

Plasminogen activator inhibitor type 1 (PAI-1)

Adiponectin

Secondary outcome:

C Reactive Protein

Interleukin-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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017