Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Corrected QT (QTc) Interval
研究概览
简要总结
To assess the cardiac effects of energy drink brands in healthy volunteers
详细描述
Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.
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 or female adults 18 - 40 years old
- •Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15
排除标准
- •Presence of any known medical condition confirmed through participant interview
- •QTc interval greater than 450 milliseconds (ms).
- •Blood pressure greater than 140/90 mmHg.
- •Current smokers
- •Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
- •Pregnant or currently breast-feeding
研究组 & 干预措施
Energy Drink Brand 1
Two 16-oz bottles of Energy Drink Brand 1
干预措施: Energy Drink Brand 1 (Dietary Supplement)
Energy Drink Brand 2
Two 16-oz bottles of Energy Drink Brand 2
干预措施: Energy Drink Brand 2 (Dietary Supplement)
Placebo
Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring
干预措施: Placebo (Other)
结局指标
主要结局
Corrected QT (QTc) Interval
时间窗: 4 hours
Electrocardiograph (ECG) Parameters
次要结局
- QT(4 hours)
- QRS(4 hours)
- Heart Rate (HR)(4 hours)
- Peripheral blood pressure(4 hours)
- PR(4 hours)
- Central blood pressure(4 hours)