NCT00661986已完成4 期
Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
University of Leipzig0 个研究点目标入组 102 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- change in mean ambulatory arterial blood pressure
研究概览
简要总结
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
- •high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
- •informed consent
排除标准
- •habituary intake of dark chocolate or cocoa products
- •mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
- •pregnancy
- •uncontrolled diabetes
- •severe comorbidity
- •change in blood pressure medication within last 6 weeks
- •participation in another trial
结局指标
主要结局
change in mean ambulatory arterial blood pressure
时间窗: 3 months
次要结局
- change in weight and BMI(3 months)
- change in various lab parameters(3 months)
研究者
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