The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity
研究概览
简要总结
The purpose of this study is to characterize the potential improvement of cocoa flavanols on exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized control study will be performed in 13 highly trained cyclist (crossover design). Participants will perform a baseline exercise testing on an ergometer. They will receive either a flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third exercise testing is performed. The order of drinks is randomized and balanced (high-flavanol-->low-flavanol drink or low-flavanol drink-->high-flavanol drink)
详细描述
13 participants (highly-trained cyclist, accustomed to exercise testing on ergometers will be enrolled (VO2max>50 ml/kg, FMD >5%, non-smokers, no medication, no diseases, age 20-36, male).
Baseline Testing:
Participants will perform a baseline testing consisting of an ergometric test with a step-wise increase of workload until exhaustion to determine lactate anaerobic threshold and cardio-pulmonary exercise capacity. Vascular function is monitored by Doppler Ultrasound.
In a second test, participants will perform a time trial (goal: as fast as possible)
Flavanol intervention Participants will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 7 days. Order is randomized and balanced. Subjects will crossover to the second arm after a washout period of 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 36 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •highly trained cyclists (VO2 peak > 50 ml/kg bodyweight)
- •refrain from cocoa ingestion during trial
- •training continued throughout testing
- •> 20 years
排除标准
- •> 36 years
- •poor endothelial function
- •acute infection
- •any chronic heart or pulmonary disease
- •arrhythmias
- •acute or chronic renal failure
- •cardio-vascular risk factors : diabetes mellitus, hypertension, hyperlipidemia
- •intake of nutrition supplements (l-arginine, creatinine)
- •intake of WADA listed doping substances
结局指标
主要结局
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity
时间窗: 7 days
次要结局
- Endothelial function(7 days)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Tienush Rassaf, MD, PhD
Heinrich-Heine University, Duesseldorf