NCT04060225终止不适用
Short-term and Intermediate-term Effects of High Volume High Caffeine Content Coffee on Blood Pressure in Young Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Mean change ambulatory blood pressure
研究概览
简要总结
The purpose of this study is to help further the understanding of the effects of commercially available high-caffeine containing coffee on blood pressure in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 18 years old
- •Male or Female
- •No prior diagnosis of hypertension
- •No prior chronic disease requiring medical intervention
- •Ability to demonstrate correct usage of ambulatory blood pressure monitoring device
排除标准
- •Age less than 18 years old
- •Prior chronic disease (such as hypertension) requiring medical intervention
- •Previously undiagnosed hypertension
- •Intolerance or allergy to coffee or caffeine
- •Inability to demonstrate correct usage of ambulatory blood pressure monitoring device
- •Inability to complete the required abstinence period prior to study interventions
- •Known pregnancy
- •Use of birth control
- •Tobacco use
- •Participation in other investigational drug studies at the time of this study
- •Medical illness requiring medical or symptomatic management
结局指标
主要结局
Mean change ambulatory blood pressure
时间窗: baseline, 24 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
次要结局
未报告次要终点
研究者
John Bisognano
Professor
University of Rochester
研究点 (2)
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