NCT05782309已完成不适用
Healthy Aging Through Dietary Intervention: Multiparametric Quantification of Function and Pathophysiology of the Aging Heart and Prevention of Age-associated Decline in Exercise Capacity Through Dietary Flavanols
Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals
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
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 50-79
排除标准
- •non-cardiac limitations of exercise capacity such as orthopedic or neurological disorders, BMI >35 kg/m2, active smoking, uncontrolled blood pressure, diabetes, COPD, atrial fibrillation, cardiomyopathy, coronary heart disease, valvular heart disease, cardiac pacemaker, acute respiratory tract infections, missing ability or missing cooperation to participate in the study
研究组 & 干预措施
Flavanol
Experimental
500 mg of flavanols twice daily
干预措施: Flavanol (Drug)
Placebo
Placebo Comparator
nutrient matched control capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Exercise capacity
时间窗: 30 days
maximum power output during cardiopulmonary exercise testing
peakVO2
时间窗: 30 days
maximum oxygen uptake during cardiopulmonary exercise testing
次要结局
- flow mediated vasodilation (FMD)(30 days)
- Oxygen pulse(30 days)
- aortic stiffness(30 days)
- diastolic strain(30 days)
- brain natriuretic peptide (nt-proBNP)(30 days)
- aortic pulse wave velocity (PWV)(30 days)
- Left ventricular function(30 days)
- left atrial volume index (LAVi)(30 days)
- diastolic strain rate (SR)(30 days)
研究者
研究点 (1)
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