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

NCT01449110 | Completed Phase 2

• 1 other identifier: CEBAS-CSIC-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Keywords

Primary prevention; Secondary prevention; Resveratrol; Grape; Cardiovascular; Nutraceutical; Food complement

Outcome Measures

Primary Outcomes (4)

• Apolipoprotein-B

  6 months

• oxidized LDL particles

  6 months

• Plasminogen activator inhibitor type 1 (PAI-1)

  6 months and 12 months

• Adiponectin

  6 months and 12 months

Secondary Outcomes (39)

• C Reactive Protein

  6 months 12 months

• Interleukin-6

  6 months and 12 months

• Interleukin-10

  6 months and 12 months

• Interleukin-18

  6 months and 12 months

• sICAM-1

  6 months and 12 months

Study Arms (6)

Placebo in PP

PLACEBO COMPARATOR

Placebo arm in primary cardiovascular prevention (PP)

Dietary Supplement: Placebo in primary cardiovascular prevention (PP)

Placebo in SP

PLACEBO COMPARATOR

Placebo arm in secondary cardiovascular prevention (SP)

Dietary Supplement: Placebo in secondary prevention

Grape extract in PP

ACTIVE COMPARATOR

Grape extract obtained without resveratrol in primary cardiovascular prevention

Dietary Supplement: Grape extract in primary prevention (PP)

Grape extract in SP

ACTIVE COMPARATOR

Grape extract without resveratrol in secondary cardiovascular prevention

Dietary Supplement: Grape extract in SP

Resveratrol-enriched grape extract in PP

EXPERIMENTAL

Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention

Dietary Supplement: Resveratrol-enriched grape extract in PP

Resveratrol-enriched grape extract in SP

EXPERIMENTAL

Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention

Dietary Supplement: Resveratrol-enriched grape extract in SP

Interventions

Placebo in primary cardiovascular prevention (PP) DIETARY_SUPPLEMENT

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

Also known as: Group A-PP

Placebo in PP

Placebo in secondary prevention DIETARY_SUPPLEMENT

12 months follow-up: 1. capsule/day (350 mg maltodextrin) for 6 months 2. capsules/day (350 mg + 350 mg maltodextrin) for 6 months

Also known as: Group A-SP

Placebo in SP

Grape extract in primary prevention (PP) DIETARY_SUPPLEMENT

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

Also known as: Group B-PP

Grape extract in PP

Grape extract in SP DIETARY_SUPPLEMENT

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

Also known as: Group B-SP

Grape extract in 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: 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

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

Resveratrol-enriched grape extract in PP

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: 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

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

Resveratrol-enriched grape extract in SP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• FOR PRIMARY AND SECONDARY PREVENTION:
• Known allergy to grapes
• Pregnancy or lactation
• Intake of nutraceuticals

Sponsors & Collaborators

• National Research Council, Spain: lead
• Hospital General Universitario Morales Meseguer: collaborator

Study Sites (1)

University Hospital Morales Meseguer

Murcia, 30008, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Secondary Prevention; FcRA76 protein, Streptococcus sp. group A; whole grape extract; Primary Prevention; Ibc proteins, Streptococcus

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Juan Carlos Espín, PhD

  National Research Council (CEBAS-CSIC, Murcia, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

ES (1)