Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital General Universitario Morales Meseguer | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo in PP | Placebo Comparator | Placebo arm in primary cardiovascular prevention (PP) |
|
| Placebo in SP | Placebo Comparator | Placebo arm in secondary cardiovascular prevention (SP) |
|
| Grape extract in PP | Active Comparator | Grape extract obtained without resveratrol in primary cardiovascular prevention |
|
| Grape extract in SP | Active Comparator | Grape extract without resveratrol in secondary cardiovascular prevention |
|
| Resveratrol-enriched grape extract in PP | Experimental | Resveratrol-enriched grape extract (Stilvid) in primary cardiovascular prevention |
|
| Resveratrol-enriched grape extract in SP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo in primary cardiovascular prevention (PP) | Dietary Supplement | 12 months follow-up:
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| C Reactive Protein | 6 months 12 months | |
| Interleukin-6 | 6 months and 12 months | |
| Interleukin-10 |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos EspÃn, PhD | National Research Council (CEBAS-CSIC, Murcia, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Morales Meseguer | Murcia | 30008 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Resveratrol-enriched grape extract (Stilvid) in secondary cardiovascular prevention |
|
|
| Placebo in secondary prevention | Dietary Supplement | 12 months follow-up:
|
|
|
| Grape extract in primary prevention (PP) | Dietary Supplement | 12 months follow-up:
|
|
|
| Grape extract in SP | Dietary Supplement | 12 months follow-up:
|
|
|
| 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:
|
|
|
| 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:
|
|
|
| 6 months and 12 months |
| Interleukin-18 | 6 months and 12 months |
| 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) | Transcriptomic study. Evaluation of the gene expression profile in PBMNCs in a diabetic sub-group from Secondary prevention. | 6 months and 12 months |
| Total homocystein levels | Total homocystein levels in plasma evaluated with UPLC-MS-QqQ | 6 months and 12 months |
| Measurement of atheroma plaque and carotid intim thickness | 12 months |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055502 | Secondary Prevention |
| C068499 | FcRA76 protein, Streptococcus sp. group A |
| C000722782 | whole grape extract |
| D011322 | Primary Prevention |
| C039214 | Ibc proteins, Streptococcus |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided