Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

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).
    


Intervention name(s): Placebo in primary cardiovascular prevention (PP); Placebo in secondary prevention; Grape extract in primary prevention (PP); Grape extract in SP; Resveratrol-enriched grape extract in PP; Resveratrol-enriched grape extract in SP
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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; 12 months follow-up:
capsule/day (350 mg maltodextrin) for 6 months
capsules/day (350 mg + 350 mg maltodextrin) for 6 months; 12 months follow-up:
capsule/day (350 mg grape extract) for 6 months
capsules/day (350 mg + 350 mg grape extract) for 6 months; 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 (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 (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
Other intervention name(s): Group A-PP; Group A-SP; Group B-PP; Group B-SP; Group C-PP; Stilvid is the key ingredient of Revidox (Actafarma, Spain); Group C-SP; Stilvid is the key ingredient of Revidox (Actafarma, Spain)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Primary prevention; Secondary prevention; Resveratrol; Grape; Cardiovascular; Nutraceutical; Food complement