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

Cardiovascular Diseases Clinical Trial

— FUNGRAPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449110
• Other study ID #: CEBAS-CSIC-1
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2011
• Last updated: November 15, 2011
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: November 2011
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Science and Innovation
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Placebo in primary cardiovascular prevention (PP)
12 months follow-up: capsule/day of placebo (350 mg maltodextrin) for 6 months capsules/day of placebo (350 mg + 350 mg maltodextrin) for 6 months
• Placebo in secondary prevention
12 months follow-up: capsule/day (350 mg maltodextrin) for 6 months capsules/day (350 mg + 350 mg maltodextrin) for 6 months
• Grape extract in primary prevention (PP)
12 months follow-up: capsule/day (350 mg grape extract) for 6 months capsules/day (350 mg + 350 mg grape extract) for 6 months
• Grape extract in SP
12 months follow-up: capsule/day (350 mg grape extract) for 6 months capsules/day (350 mg + 350 mg grape extract) for 6 months
• Resveratrol-enriched grape extract in PP
Resveratrol-enriched grape extract (Stilvid) is obtained from grapes treated with UVC illumination. Similar polyphenolic content to conventional grape extract used in the arms 'Grape extract in PP' and 'Grape extract in SP' but containing 8 mg resveratrol. 12 months follow-up: capsule/day (350 mg resveratrol-enriched grape extract) for 6 months capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months
• Resveratrol-enriched grape extract in SP
Resveratrol-enriched grape extract (Stilvid) is obtained from grapes treated with UVC illumination. Similar polyphenolic content to conventional grape extract used in the arms 'Grape extract in PP' and 'Grape extract in SP' but containing 8 mg resveratrol. 12 months follow-up: capsule/day (350 mg resveratrol-enriched grape extract) for 6 months capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months

Locations

Country	Name	City	State
Spain	University Hospital Morales Meseguer	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Hospital General Universitario Morales Meseguer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apolipoprotein-B		6 months	No
Primary	oxidized LDL particles		6 months	No
Primary	Plasminogen activator inhibitor type 1 (PAI-1)		6 months and 12 months	No
Primary	Adiponectin		6 months and 12 months	No
Secondary	C Reactive Protein		6 months 12 months	No
Secondary	Interleukin-6		6 months and 12 months	No
Secondary	Interleukin-10		6 months and 12 months	No
Secondary	Interleukin-18		6 months and 12 months	No
Secondary	sICAM-1		6 months and 12 months	No
Secondary	sVCAM-1		6 months and 12 months	No
Secondary	D-dimer		6 months and 12 months	No
Secondary	Fibrinogen		6 months and 12 months	No
Secondary	Glycated hemoglobin		6 months and 12 months	No
Secondary	Glucose		6 months and 12 months	No
Secondary	GGT		6 months and 12 months	Yes
Secondary	AST		6 months and 12 months	Yes
Secondary	Urate		6 months and 12 months	Yes
Secondary	ALT		6 months and 12 months	Yes
Secondary	LDH		6 months and 12 months	Yes
Secondary	TSH		6 months and 12 months	Yes
Secondary	Thyroxine		6 months and 12 months	Yes
Secondary	ALP		6 months and 12 months	Yes
Secondary	CPK		6 months and 12 months	Yes
Secondary	Bilirubin		6 months and 12 months	Yes
Secondary	Creatinin		6 months and 12 months	Yes
Secondary	Albumin		6 months and 12 months	Yes
Secondary	Total cholesterol		6 months and 12 months	No
Secondary	LDL-cholesterol		6 months and 12 months	No
Secondary	HDL-cholesterol		6 months and 12 months	No
Secondary	Triglycerides		6 months and 12 months	No
Secondary	Hematocrit		6 months and 12 months	Yes
Secondary	Hemoglobin		6 months and 12 months	Yes
Secondary	Mean corpuscular volume		6 months and 12 months	Yes
Secondary	Leucocytes		6 months and 12 months	Yes
Secondary	Neutrophils		6 months and 12 months	Yes
Secondary	Lymphocytes		6 months and 12 months	Yes
Secondary	Eosinophils		6 months and 12 months	Yes
Secondary	Platelets		6 months and 12 months	Yes
Secondary	Mean platelet volume		6 months and 12 months	Yes
Secondary	Sedimentation rate volume		6 months and 12 months	Yes
Secondary	Gene expression profile in peripheral blood mononuclear cells (PBMNCs)	Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention.	6 months and 12 months	No
Secondary	Total homocystein levels	Total homocystein levels in plasma evaluated with UPLC-MS-QqQ	6 months and 12 months	No
Secondary	Measurement of atheroma plaque and carotid intim thickness		12 months	No