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

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).

Conditions

• Cardiovascular Diseases

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

• Hospital General Universitario Morales Meseguer

  collaborator OTHER

• National Research Council, Spain

  lead OTHER_GOV

Principal Investigators

• Juan Carlos Espín, PhD · National Research Council (CEBAS-CSIC, Murcia, Spain)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2010-10-31

Completion

2011-03-31

Countries

• Spain

Study Locations