NCT01449110已完成2 期
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
National Research Council, Spain2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Adiponectin
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •FOR PRIMARY AND SECONDARY PREVENTION:
- •Patients who do not satisfy inclusion criteria and:
- •Known allergy to grapes
- •Pregnancy or lactation
- •Intake of nutraceuticals
结局指标
主要结局
Adiponectin
时间窗: 6 months and 12 months
Apolipoprotein-B
时间窗: 6 months
oxidized LDL particles
时间窗: 6 months
Plasminogen activator inhibitor type 1 (PAI-1)
时间窗: 6 months and 12 months
次要结局
- 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)
- 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)
- Total homocystein levels(6 months and 12 months)
- Measurement of atheroma plaque and carotid intim thickness(12 months)
研究者
Juan Carlos Espín de Gea
Research Professor
National Research Council, Spain
研究点 (2)
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