NCT01449110

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National Research Council, Spain · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2011-10-07
• Last updated: 2011-11-16

Locations

1 site across 1 country: Spain