University Hospital Morales Meseguer
Murcia, 30008, Spain
NCT Number: NCT01449110
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).
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Murcia, 30008, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
FOR PRIMARY PREVENTION:
FOR SECONDARY PREVENTION:
Exclusion criteria
FOR PRIMARY AND SECONDARY PREVENTION:
12 months follow-up:
Other names: Group A-PP
12 months follow-up:
Other names: Group A-SP
12 months follow-up:
Other names: Group B-PP
12 months follow-up:
Other names: Group B-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:
Other names: Group C-PP, Stilvid is the key ingredient of Revidox (Actafarma, Spain)
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:
Other names: Group C-SP, Stilvid is the key ingredient of Revidox (Actafarma, Spain)
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Time frame: 6 months and 12 months
Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention.
Time frame: 6 months and 12 months
Total homocystein levels in plasma evaluated with UPLC-MS-QqQ
Time frame: 12 months
National Research Council, Spain
Other Gov
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
Acronym: FUNGRAPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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