NCT01453166已完成不适用
The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
详细描述
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
- •Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
- •Asymptomatic carotid artery disease;
- •Body mass index> 25 kg/m2 for adults and> 28 kg/m2 for seniors
排除标准
- •Neurocognitive or psychiatric condition;
- •Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
- •Pregnancy or breast feeding.
- •Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
- •Renal impairment defined as creatinine values higher than 1.5 mg/dL.
结局指标
主要结局
Systolic Blood Pressure
时间窗: 12 weeks
Change From Baseline in systolic blood pressure
Total Cholesterol
时间窗: 12 weeks
Change From Baseline in total Cholesterol
次要结局
- Blood Glucose(12 weeks)
- Weight(12 weeks)
- Waist Circumference(12 weeks)
研究者
研究点 (2)
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