AzTrials
AzTrials

Cardiovascular DiseasesPhase 2FUNGRAPENCT01449110

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

A Phase 2 study testing Grape extract in primary prevention (PP), Grape extract in SP and Resveratrol-enriched grape extract in PP in people with Cardiovascular Diseases, run by National Research Council, Spain at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Grape extract in primary prevention (PP), Grape extract in SP and Resveratrol-enriched grape extract in PP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSpain
Study dates
Apr 2009to Mar 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 15Show fewer
  • 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.

Who cannot join

  • FOR PRIMARY AND SECONDARY PREVENTION:
  • Patients who do not satisfy inclusion criteria and:
  • Known allergy to grapes
  • Pregnancy or lactation
  • Intake of nutraceuticals

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Hospital Morales Meseguer

    Murcia, 30008

Other trials in Spain

About this study

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

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).

Being tested
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
Keywords
Primary prevention, Secondary prevention, Resveratrol, Grape, Cardiovascular, Nutraceutical, Food complement
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo in primary cardiovascular prevention (PP)Dietary supplement

    Also called Group A-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

  • Placebo in secondary preventionDietary supplement

    Also called Group A-SP

    12 months follow-up:

    1. capsule/day (350 mg maltodextrin) for 6 months
    2. capsules/day (350 mg + 350 mg maltodextrin) for 6 months

  • Grape extract in primary prevention (PP)Dietary supplement

    Also called Group B-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

  • Grape extract in SPDietary supplement

    Also called Group B-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

  • Resveratrol-enriched grape extract in PPDietary supplement

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

    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

  • Resveratrol-enriched grape extract in SPDietary supplement

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

    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
Study groups in NCT01449110
Study groupRoleWhat they receive
Placebo in PPPlacebo comparatorPlacebo arm in primary cardiovascular prevention (PP)
Receives: Dietary Supplement: Placebo in primary cardiovascular prevention (PP)
Placebo in SPPlacebo comparatorPlacebo arm in secondary cardiovascular prevention (SP)
Receives: Dietary Supplement: Placebo in secondary prevention
Grape extract in PPActive comparatorGrape extract obtained without resveratrol in primary cardiovascular prevention
Receives: Dietary Supplement: Grape extract in primary prevention (PP)
Grape extract in SPActive comparatorGrape extract without resveratrol in secondary cardiovascular prevention
Receives: Dietary Supplement: Grape extract in SP
Resveratrol-enriched grape extract in PPExperimentalResveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention
Receives: Dietary Supplement: Resveratrol-enriched grape extract in PP
Resveratrol-enriched grape extract in SPExperimentalResveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention
Receives: Dietary Supplement: Resveratrol-enriched grape extract in SP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apolipoprotein-B

    Measured: 6 months

  2. oxidized LDL particles

    Measured: 6 months

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

    Measured: 6 months and 12 months

  4. Adiponectin

    Measured: 6 months and 12 months

Secondary outcomes (39)

  1. C Reactive Protein

    Measured: 6 months 12 months

  2. Interleukin-6

    Measured: 6 months and 12 months

  3. Interleukin-10

    Measured: 6 months and 12 months

  4. Interleukin-18

    Measured: 6 months and 12 months

  5. sICAM-1

    Measured: 6 months and 12 months

  6. sVCAM-1

    Measured: 6 months and 12 months

  7. D-dimer

    Measured: 6 months and 12 months

  8. Fibrinogen

    Measured: 6 months and 12 months

  9. Glycated hemoglobin

    Measured: 6 months and 12 months

  10. Glucose

    Measured: 6 months and 12 months

  11. GGT

    Measured: 6 months and 12 months

  12. AST

    Measured: 6 months and 12 months

  13. Urate

    Measured: 6 months and 12 months

  14. ALT

    Measured: 6 months and 12 months

  15. LDH

    Measured: 6 months and 12 months

  16. TSH

    Measured: 6 months and 12 months

  17. Thyroxine

    Measured: 6 months and 12 months

  18. ALP

    Measured: 6 months and 12 months

  19. CPK

    Measured: 6 months and 12 months

  20. Bilirubin

    Measured: 6 months and 12 months

  21. Creatinin

    Measured: 6 months and 12 months

  22. Albumin

    Measured: 6 months and 12 months

  23. Total cholesterol

    Measured: 6 months and 12 months

  24. LDL-cholesterol

    Measured: 6 months and 12 months

  25. HDL-cholesterol

    Measured: 6 months and 12 months

  26. Triglycerides

    Measured: 6 months and 12 months

  27. Hematocrit

    Measured: 6 months and 12 months

  28. Hemoglobin

    Measured: 6 months and 12 months

  29. Mean corpuscular volume

    Measured: 6 months and 12 months

  30. Leucocytes

    Measured: 6 months and 12 months

  31. Neutrophils

    Measured: 6 months and 12 months

  32. Lymphocytes

    Measured: 6 months and 12 months

  33. Eosinophils

    Measured: 6 months and 12 months

  34. Platelets

    Measured: 6 months and 12 months

  35. Mean platelet volume

    Measured: 6 months and 12 months

  36. Sedimentation rate volume

    Measured: 6 months and 12 months

  37. Gene expression profile in peripheral blood mononuclear cells (PBMNCs)

    Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention.

    Measured: 6 months and 12 months

  38. Total homocystein levels

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

    Measured: 6 months and 12 months

  39. Measurement of atheroma plaque and carotid intim thickness

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2011 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01449110
Sponsor's protocol ID
CEBAS-CSIC-1
Acronym
FUNGRAPE
Status last verified
Nov 2011
First submitted
6 Oct 2011
Last updated
16 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Grape extract in primary prevention (PP), Grape extract in SP and Resveratrol-enriched grape extract in PP in people with Cardiovascular Diseases, run by National Research Council, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apolipoprotein-B (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in