NCT02023723已完成不适用
Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
David Grant U.S. Air Force Medical Center2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- QT/QTc measured on an office ECG
研究概览
简要总结
This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
- •Ages 18-40 years old
- •Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1 and
- •They must also refrain from consuming additional caffeine or energy drinks during the 24-hour observation time on days 1-2 and 8-9.
排除标准
- •Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
- •Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
- •Presence of any known medical condition, confirmed through participant interview. Examples of these are:
- •Hypertension
- •Thyroid disease
- •Type 1 or 2 diabetes mellitus
- •Recurrent headaches
- •Depression, currently receiving treatment (due to possible drug interactions)
- •Any psychiatric condition or neurological disorder
- •History of alcohol or drug abuse in the previous 5 years
- •Ever been diagnosed or told they have or had renal or hepatic dysfunction
- •Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements. Daily basis is defined as greater than 2 days per week.
- •Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1 and 8)
- •All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
- •If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well
结局指标
主要结局
QT/QTc measured on an office ECG
时间窗: 6 hours over 5 visits
次要结局
- Peripheral Blood pressure(6 hours with 5 visits)
- Central blood pressure(6 hours over 5 visits)
- Augmentation Index, pulse wave(6 hours over 5 visits)
研究者
研究点 (2)
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