Cardiovascular Diseases
Conditions
Keywords
Primary prevention, Secondary prevention, Resveratrol, Grape, Cardiovascular, Nutraceutical, Food complement
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).
Interventions
DIETARY_SUPPLEMENTPlacebo 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
DIETARY_SUPPLEMENTPlacebo 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
DIETARY_SUPPLEMENTGrape 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
DIETARY_SUPPLEMENTGrape 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
DIETARY_SUPPLEMENTResveratrol-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
DIETARY_SUPPLEMENTResveratrol-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
Sponsors
Hospital General Universitario Morales Meseguer
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| sICAM-1 | 6 months and 12 months | — |
| sVCAM-1 | 6 months and 12 months | — |
| D-dimer | 6 months and 12 months | — |
| Fibrinogen | 6 months and 12 months | — |
| Glycated hemoglobin | 6 months and 12 months | — |
| Glucose | 6 months and 12 months | — |
| GGT | 6 months and 12 months | — |
| AST | 6 months and 12 months | — |
| Urate | 6 months and 12 months | — |
| ALT | 6 months and 12 months | — |
| LDH | 6 months and 12 months | — |
| TSH | 6 months and 12 months | — |
| Thyroxine | 6 months and 12 months | — |
| ALP | 6 months and 12 months | — |
| CPK | 6 months and 12 months | — |
| Bilirubin | 6 months and 12 months | — |
| Creatinin | 6 months and 12 months | — |
| Albumin | 6 months and 12 months | — |
| Total cholesterol | 6 months and 12 months | — |
| LDL-cholesterol | 6 months and 12 months | — |
| HDL-cholesterol | 6 months and 12 months | — |
| Triglycerides | 6 months and 12 months | — |
| Hematocrit | 6 months and 12 months | — |
| Hemoglobin | 6 months and 12 months | — |
| Mean corpuscular volume | 6 months and 12 months | — |
| Leucocytes | 6 months and 12 months | — |
| Neutrophils | 6 months and 12 months | — |
| Lymphocytes | 6 months and 12 months | — |
| Eosinophils | 6 months and 12 months | — |
| Platelets | 6 months and 12 months | — |
| Mean platelet volume | 6 months and 12 months | — |
| Sedimentation rate volume | 6 months and 12 months | — |
| Gene expression profile in peripheral blood mononuclear cells (PBMNCs) | 6 months and 12 months | Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention. |
| C Reactive Protein | 6 months 12 months | — |
| Measurement of atheroma plaque and carotid intim thickness | 12 months | — |
| Total homocystein levels | 6 months and 12 months | Total homocystein levels in plasma evaluated with UPLC-MS-QqQ |
| Interleukin-6 | 6 months and 12 months | — |
| Interleukin-10 | 6 months and 12 months | — |
| Interleukin-18 | 6 months and 12 months | — |
Countries
Spain
Outcome results
None listed