NCT01421979已完成不适用
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Heart-rate-variability (HRV)
研究概览
简要总结
The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •healthy (no acute or chronic desease)
- •BMI 20,0 - 25,9 kg/m2
- •moderate and non-regular consumption of alcohol, EDs and coffee
排除标准
- •pregnancy
- •regular medication (oral contraceptives permitted)
- •hypertension and other deseases of the cardiovascular system
- •liver-deseases
- •psychiatric deseases
- •other relevant deseases
- •(former) alcoholics
- •non-compliance to the study-protocol
- •simultaneous participation in another clinical trial
- •retraction of the written informed consent
结局指标
主要结局
Heart-rate-variability (HRV)
时间窗: during 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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