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

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ClinicalTrials.gov Identifier: NCT01449110
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : November 16, 2011
Sponsor:
Collaborator:
Hospital General Universitario Morales Meseguer
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain

October 6, 2011
October 7, 2011
November 16, 2011
April 2009
October 2010   (Final data collection date for primary outcome measure)
  • Apolipoprotein-B [ Time Frame: 6 months ]
  • oxidized LDL particles [ Time Frame: 6 months ]
  • Plasminogen activator inhibitor type 1 (PAI-1) [ Time Frame: 6 months and 12 months ]
  • Adiponectin [ Time Frame: 6 months and 12 months ]
Same as current
Complete list of historical versions of study NCT01449110 on ClinicalTrials.gov Archive Site
  • C Reactive Protein [ Time Frame: 6 months 12 months ]
  • Interleukin-6 [ Time Frame: 6 months and 12 months ]
  • Interleukin-10 [ Time Frame: 6 months and 12 months ]
  • Interleukin-18 [ Time Frame: 6 months and 12 months ]
  • sICAM-1 [ Time Frame: 6 months and 12 months ]
  • sVCAM-1 [ Time Frame: 6 months and 12 months ]
  • D-dimer [ Time Frame: 6 months and 12 months ]
  • Fibrinogen [ Time Frame: 6 months and 12 months ]
  • Glycated hemoglobin [ Time Frame: 6 months and 12 months ]
  • Glucose [ Time Frame: 6 months and 12 months ]
  • GGT [ Time Frame: 6 months and 12 months ]
  • AST [ Time Frame: 6 months and 12 months ]
  • Urate [ Time Frame: 6 months and 12 months ]
  • ALT [ Time Frame: 6 months and 12 months ]
  • LDH [ Time Frame: 6 months and 12 months ]
  • TSH [ Time Frame: 6 months and 12 months ]
  • Thyroxine [ Time Frame: 6 months and 12 months ]
  • ALP [ Time Frame: 6 months and 12 months ]
  • CPK [ Time Frame: 6 months and 12 months ]
  • Bilirubin [ Time Frame: 6 months and 12 months ]
  • Creatinin [ Time Frame: 6 months and 12 months ]
  • Albumin [ Time Frame: 6 months and 12 months ]
  • Total cholesterol [ Time Frame: 6 months and 12 months ]
  • LDL-cholesterol [ Time Frame: 6 months and 12 months ]
  • HDL-cholesterol [ Time Frame: 6 months and 12 months ]
  • Triglycerides [ Time Frame: 6 months and 12 months ]
  • Hematocrit [ Time Frame: 6 months and 12 months ]
  • Hemoglobin [ Time Frame: 6 months and 12 months ]
  • Mean corpuscular volume [ Time Frame: 6 months and 12 months ]
  • Leucocytes [ Time Frame: 6 months and 12 months ]
  • Neutrophils [ Time Frame: 6 months and 12 months ]
  • Lymphocytes [ Time Frame: 6 months and 12 months ]
  • Eosinophils [ Time Frame: 6 months and 12 months ]
  • Platelets [ Time Frame: 6 months and 12 months ]
  • Mean platelet volume [ Time Frame: 6 months and 12 months ]
  • Sedimentation rate volume [ Time Frame: 6 months and 12 months ]
  • Gene expression profile in peripheral blood mononuclear cells (PBMNCs) [ 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.
  • Total homocystein levels [ Time Frame: 6 months and 12 months ]
    Total homocystein levels in plasma evaluated with UPLC-MS-QqQ
  • Measurement of atheroma plaque and carotid intim thickness [ Time Frame: 12 months ]
  • C Reactive Protein [ Time Frame: 6 months 12 months ]
  • Interleukin-6 [ Time Frame: 6 months and 12 months ]
  • Interleukin-10 [ Time Frame: 6 months and 12 months ]
  • Interleukin-18 [ Time Frame: 6 months and 12 months ]
  • sICAM-1 [ Time Frame: 6 months and 12 months ]
  • sVCAM-1 [ Time Frame: 6 months and 12 months ]
  • D-dimer [ Time Frame: 6 months and 12 months ]
  • Fibrinogen [ Time Frame: 6 months and 12 months ]
  • Glycated hemoglobin [ Time Frame: 6 months and 12 months ]
  • Glucose [ Time Frame: 6 months and 12 months ]
  • GGT [ Time Frame: 6 months and 12 months ]
  • AST [ Time Frame: 6 months and 12 months ]
  • Urate [ Time Frame: 6 months and 12 months ]
  • ALT [ Time Frame: 6 months and 12 months ]
  • LDH [ Time Frame: 6 months and 12 months ]
  • TSH [ Time Frame: 6 months and 12 months ]
  • Thyroxine [ Time Frame: 6 months and 12 months ]
  • ALP [ Time Frame: 6 months and 12 months ]
  • CPK [ Time Frame: 6 months and 12 months ]
  • Bilirubin [ Time Frame: 6 months and 12 months ]
  • Creatinin [ Time Frame: 6 months and 12 months ]
  • Albumin [ Time Frame: 6 months and 12 months ]
  • Total cholesterol [ Time Frame: 6 months and 12 months ]
  • LDL-cholesterol [ Time Frame: 6 months and 12 months ]
  • HDL-cholesterol [ Time Frame: 6 months and 12 months ]
  • Triglycerides [ Time Frame: 6 months and 12 months ]
  • Hematocrit [ Time Frame: 6 months and 12 months ]
  • Hemoglobin [ Time Frame: 6 months and 12 months ]
  • Mean corpuscular volume [ Time Frame: 6 months and 12 months ]
  • Leucocytes [ Time Frame: 6 months and 12 months ]
  • Neutrophils [ Time Frame: 6 months and 12 months ]
  • Lymphocytes [ Time Frame: 6 months and 12 months ]
  • Eosinophils [ Time Frame: 6 months and 12 months ]
  • Platelets [ Time Frame: 6 months and 12 months ]
  • Mean platelet volume [ Time Frame: 6 months and 12 months ]
  • Sedimentation rate volume [ Time Frame: 6 months and 12 months ]
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Diseases
  • 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
    Other Name: Group A-PP
  • 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
    Other Name: Group A-SP
  • 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
    Other Name: Group B-PP
  • 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
    Other Name: Group B-SP
  • 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
    Other Names:
    • Group C-PP
    • Stilvid is the key ingredient of Revidox (Actafarma, Spain)
  • 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
    Other Names:
    • Group C-SP
    • Stilvid is the key ingredient of Revidox (Actafarma, Spain)
  • Placebo Comparator: Placebo in PP
    Placebo arm in primary cardiovascular prevention (PP)
    Intervention: Dietary Supplement: Placebo in primary cardiovascular prevention (PP)
  • Placebo Comparator: Placebo in SP
    Placebo arm in secondary cardiovascular prevention (SP)
    Intervention: Dietary Supplement: Placebo in secondary prevention
  • Active Comparator: Grape extract in PP
    Grape extract obtained without resveratrol in primary cardiovascular prevention
    Intervention: Dietary Supplement: Grape extract in primary prevention (PP)
  • Active Comparator: Grape extract in SP
    Grape extract without resveratrol in secondary cardiovascular prevention
    Intervention: Dietary Supplement: Grape extract in SP
  • Experimental: Resveratrol-enriched grape extract in PP
    Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention
    Intervention: Dietary Supplement: Resveratrol-enriched grape extract in PP
  • Experimental: Resveratrol-enriched grape extract in SP
    Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention
    Intervention: Dietary Supplement: Resveratrol-enriched grape extract in SP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
March 2011
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

FOR PRIMARY PREVENTION:

  • 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.

      Exclusion Criteria:

      FOR PRIMARY AND SECONDARY PREVENTION:

  • Patients who do not satisfy inclusion criteria and:

    1. Known allergy to grapes
    2. Pregnancy or lactation
    3. Intake of nutraceuticals
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01449110
CEBAS-CSIC-1
No
Not Provided
Not Provided
Juan Carlos Espín de Gea, National Research Council, Spain
National Research Council, Spain
Hospital General Universitario Morales Meseguer
Principal Investigator: Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
National Research Council, Spain
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP