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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 6, 2011
First Posted Date  ICMJE October 7, 2011
Last Update Posted Date November 16, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
Official Title  ICMJE 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
Brief 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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2011)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01449110
Other Study ID Numbers  ICMJE CEBAS-CSIC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan Carlos Espín de Gea, National Research Council, Spain
Study Sponsor  ICMJE National Research Council, Spain
Collaborators  ICMJE Hospital General Universitario Morales Meseguer
Investigators  ICMJE
Principal Investigator: Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
PRS Account National Research Council, Spain
Verification Date November 2011

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