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Completed

NCT Number: NCT01449110

Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention 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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Morales Meseguer

Murcia, 30008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Active smoking (10 cigarettes or more per day).
  • Arterial hypertension (>= 140/90 mmHg).
  • Hypercholesterolemia (LDL-cholesterol >130 mg/dL and/or HDL-cholesterol < 45 mg/dL in women and 50 mg/dL in men).
  • 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:
  • Age between 18 and 80 years.
  • Ejection fraction of left ventricle >=45%.
  • Functional status I or II according to the New York Heart Association.
  • Clinic stability in the recruitment (no symptoms of thoracic pain during the last month).
  • 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:
  • Known allergy to grapes
  • Pregnancy or lactation
  • Intake of nutraceuticals

Treatment and study plan

Placebo in primary cardiovascular prevention (PP)

Dietary Supplement

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

Other names: Group A-PP

Placebo in secondary prevention

Dietary Supplement

12 months follow-up:

  • capsule/day (350 mg maltodextrin) for 6 months
  • capsules/day (350 mg + 350 mg maltodextrin) for 6 months

Other names: Group A-SP

Grape extract in primary prevention (PP)

Dietary Supplement

12 months follow-up:

  • capsule/day (350 mg grape extract) for 6 months
  • capsules/day (350 mg + 350 mg grape extract) for 6 months

Other names: Group B-PP

Grape extract in SP

Dietary Supplement

12 months follow-up:

  • capsule/day (350 mg grape extract) for 6 months
  • capsules/day (350 mg + 350 mg grape extract) for 6 months

Other names: Group B-SP

Resveratrol-enriched grape extract in PP

Dietary Supplement

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 names: Group C-PP, Stilvid is the key ingredient of Revidox (Actafarma, Spain)

Resveratrol-enriched grape extract in SP

Dietary Supplement

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 names: Group C-SP, Stilvid is the key ingredient of Revidox (Actafarma, Spain)

Primary outcomes

  1. Apolipoprotein-B

    Time frame: 6 months

  2. oxidized LDL particles

    Time frame: 6 months

  3. Plasminogen activator inhibitor type 1 (PAI-1)

    Time frame: 6 months and 12 months

  4. Adiponectin

    Time frame: 6 months and 12 months

Secondary outcomes

  1. C Reactive Protein

    Time frame: 6 months 12 months

  2. Interleukin-6

    Time frame: 6 months and 12 months

  3. Interleukin-10

    Time frame: 6 months and 12 months

  4. Interleukin-18

    Time frame: 6 months and 12 months

  5. sICAM-1

    Time frame: 6 months and 12 months

  6. sVCAM-1

    Time frame: 6 months and 12 months

  7. D-dimer

    Time frame: 6 months and 12 months

  8. Fibrinogen

    Time frame: 6 months and 12 months

  9. Glycated hemoglobin

    Time frame: 6 months and 12 months

  10. Glucose

    Time frame: 6 months and 12 months

  11. GGT

    Time frame: 6 months and 12 months

  12. AST

    Time frame: 6 months and 12 months

  13. Urate

    Time frame: 6 months and 12 months

  14. ALT

    Time frame: 6 months and 12 months

  15. LDH

    Time frame: 6 months and 12 months

  16. TSH

    Time frame: 6 months and 12 months

  17. Thyroxine

    Time frame: 6 months and 12 months

  18. ALP

    Time frame: 6 months and 12 months

  19. CPK

    Time frame: 6 months and 12 months

  20. Bilirubin

    Time frame: 6 months and 12 months

  21. Creatinin

    Time frame: 6 months and 12 months

  22. Albumin

    Time frame: 6 months and 12 months

  23. Total cholesterol

    Time frame: 6 months and 12 months

  24. LDL-cholesterol

    Time frame: 6 months and 12 months

  25. HDL-cholesterol

    Time frame: 6 months and 12 months

  26. Triglycerides

    Time frame: 6 months and 12 months

  27. Hematocrit

    Time frame: 6 months and 12 months

  28. Hemoglobin

    Time frame: 6 months and 12 months

  29. Mean corpuscular volume

    Time frame: 6 months and 12 months

  30. Leucocytes

    Time frame: 6 months and 12 months

  31. Neutrophils

    Time frame: 6 months and 12 months

  32. Lymphocytes

    Time frame: 6 months and 12 months

  33. Eosinophils

    Time frame: 6 months and 12 months

  34. Platelets

    Time frame: 6 months and 12 months

  35. Mean platelet volume

    Time frame: 6 months and 12 months

  36. Sedimentation rate volume

    Time frame: 6 months and 12 months

  37. 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.

  38. Total homocystein levels

    Time frame: 6 months and 12 months

    Total homocystein levels in plasma evaluated with UPLC-MS-QqQ

  39. Measurement of atheroma plaque and carotid intim thickness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Hospital General Universitario Morales Meseguer

Registry information

Official study 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

Acronym: FUNGRAPE

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 7, 2011
Registry last updated
Nov 16, 2011

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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