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临床试验/NCT02401776
NCT02401776已完成不适用

An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
QT interval will be measured in msec

研究概览

简要总结

  • The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG.
  • The secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects).

To place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: Starbuck's K-cup Breakfast Blend.

详细描述

This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •BMI between 24 - 29

排除标准

  • •Resting heart rate below 60 bpm
  • •Resting heart rate above 88 bpm
  • •Cardiovascular or metabolic disease

研究组 & 干预措施

small dose monster energy drink

Experimental

This will be a small dose of monster energy drink

干预措施: Monster Energy Drink (Dietary Supplement)

medium dose monster energy drink

Experimental

This will be a medium dose of monster energy drink

干预措施: Monster Energy Drink (Dietary Supplement)

coffee

Active Comparator

This will be a coffee group and will drink Starbuck's K-cup Breakfast Blend. This will be mixed according to packing instructions and will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 11 ounce cup of coffee for a person weighing 75 kg).

干预措施: Monster Energy Drink (Dietary Supplement)

coffee

Active Comparator

This will be a coffee group and will drink Starbuck's K-cup Breakfast Blend. This will be mixed according to packing instructions and will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 11 ounce cup of coffee for a person weighing 75 kg).

干预措施: Coffee (Dietary Supplement)

medium dose monster energy drink

Experimental

This will be a medium dose of monster energy drink

干预措施: Coffee (Dietary Supplement)

small dose monster energy drink

Experimental

This will be a small dose of monster energy drink

干预措施: Coffee (Dietary Supplement)

结局指标

主要结局

QT interval will be measured in msec

时间窗: 19 hrs

The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec.

次要结局

  • Heart rate will be measured as beats per minute.(19 hrs)
  • Blood Pressure will be measured in the brachial artery as mmHG(19 hrs)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert M. Brothers

Assistant Professor

University of Texas at Austin

研究点 (1)

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