Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
NCT ID: NCT01449110
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2009-04-30
2011-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo in PP
Placebo arm in primary cardiovascular prevention (PP)
Placebo in primary cardiovascular prevention (PP)
12 months follow-up:
1. capsule/day of placebo (350 mg maltodextrin) for 6 months
2. capsules/day of placebo (350 mg + 350 mg maltodextrin) for 6 months
Placebo in SP
Placebo arm in secondary cardiovascular prevention (SP)
Placebo in secondary prevention
12 months follow-up:
1. capsule/day (350 mg maltodextrin) for 6 months
2. capsules/day (350 mg + 350 mg maltodextrin) for 6 months
Grape extract in PP
Grape extract obtained without resveratrol in primary cardiovascular prevention
Grape extract in primary prevention (PP)
12 months follow-up:
1. capsule/day (350 mg grape extract) for 6 months
2. capsules/day (350 mg + 350 mg grape extract) for 6 months
Grape extract in SP
Grape extract without resveratrol in secondary cardiovascular prevention
Grape extract in SP
12 months follow-up:
1. capsule/day (350 mg grape extract) for 6 months
2. capsules/day (350 mg + 350 mg grape extract) for 6 months
Resveratrol-enriched grape extract in PP
Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention
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:
1. capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
2. capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months
Resveratrol-enriched grape extract in SP
Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention
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:
1. capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
2. capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months
Interventions
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Placebo in primary cardiovascular prevention (PP)
12 months follow-up:
1. capsule/day of placebo (350 mg maltodextrin) for 6 months
2. capsules/day of placebo (350 mg + 350 mg maltodextrin) for 6 months
Placebo in secondary prevention
12 months follow-up:
1. capsule/day (350 mg maltodextrin) for 6 months
2. capsules/day (350 mg + 350 mg maltodextrin) for 6 months
Grape extract in primary prevention (PP)
12 months follow-up:
1. capsule/day (350 mg grape extract) for 6 months
2. capsules/day (350 mg + 350 mg grape extract) for 6 months
Grape extract in SP
12 months follow-up:
1. capsule/day (350 mg grape extract) for 6 months
2. 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:
1. capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
2. 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:
1. capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
2. capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
1. Known allergy to grapes
2. Pregnancy or lactation
3. Intake of nutraceuticals
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Hospital General Universitario Morales Meseguer
OTHER
National Research Council, Spain
OTHER_GOV
Responsible Party
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Juan Carlos Espín de Gea
Research Professor
Principal Investigators
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Juan Carlos Espín, PhD
Role: PRINCIPAL_INVESTIGATOR
National Research Council (CEBAS-CSIC, Murcia, Spain)
Locations
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University Hospital Morales Meseguer
Murcia, , Spain
Countries
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Other Identifiers
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CEBAS-CSIC-1
Identifier Type: -
Identifier Source: org_study_id