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

This study has been completed.
Sponsor:
Collaborator:
University Hospital Morales Meseguer (Murcia, Spain)
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT01449110
First received: October 6, 2011
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Cardiovascular Diseases
 Dietary Supplement: Placebo in primary cardiovascular prevention (PP)
Dietary Supplement: Placebo in secondary prevention
Dietary Supplement: Grape extract in primary prevention (PP)
Dietary Supplement: Grape extract in SP
Dietary Supplement: Resveratrol-enriched grape extract in PP
Dietary Supplement: Resveratrol-enriched grape extract in SP
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Resveratrol
U.S. FDA Resources

Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Apolipoprotein-B [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • oxidized LDL particles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Plasminogen activator inhibitor type 1 (PAI-1) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C Reactive Protein [ Time Frame: 6 months 12 months ] [ Designated as safety issue: No ]
  • Interleukin-6 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Interleukin-10 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Interleukin-18 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • sICAM-1 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • sVCAM-1 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • D-dimer [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Fibrinogen [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Glycated hemoglobin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • GGT [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • AST [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Urate [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • ALT [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • LDH [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • TSH [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Thyroxine [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • ALP [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • CPK [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Bilirubin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Creatinin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Albumin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Total cholesterol [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Hematocrit [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Hemoglobin [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Mean corpuscular volume [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Leucocytes [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Neutrophils [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Lymphocytes [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Eosinophils [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Platelets [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Mean platelet volume [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Sedimentation rate volume [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Gene expression profile in peripheral blood mononuclear cells (PBMNCs) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total homocystein levels in plasma evaluated with UPLC-MS-QqQ

  • Measurement of atheroma plaque and carotid intim thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo in PP
Placebo arm in primary cardiovascular prevention (PP)
 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
Placebo Comparator: Placebo in SP
Placebo arm in secondary cardiovascular prevention (SP)
 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
Active Comparator: Grape extract in PP
Grape extract obtained without resveratrol in primary cardiovascular prevention
 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
Active Comparator: Grape extract in SP
Grape extract without resveratrol in secondary cardiovascular prevention
 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
Experimental: Resveratrol-enriched grape extract in PP
Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention
 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)
Experimental: Resveratrol-enriched grape extract in SP
Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention
 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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449110

Locations
Spain
University Hospital Morales Meseguer
Murcia, Spain, 30008
Sponsors and Collaborators
National Research Council, Spain
University Hospital Morales Meseguer (Murcia, Spain)
Investigators
Principal Investigator: Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
  More Information

No publications provided

Responsible Party: Juan Carlos Espín de Gea, Research Professor, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01449110     History of Changes
Other Study ID Numbers: CEBAS-CSIC-1
Study First Received: October 6, 2011
Last Updated: November 15, 2011
Health Authority: Spain: Ministry of Science and Innovation

Keywords provided by National Research Council, Spain:
Primary prevention
Secondary prevention
Resveratrol
Grape
 Cardiovascular
Nutraceutical
Food complement

Additional relevant MeSH terms:
Resveratrol
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013