The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- QTc interval
研究概览
简要总结
Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.
详细描述
The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.
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
- Triple (Participant, Care Provider, 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 each study day
- •Participants must be willing to fast 10 hours prior to each study day
- •Participants must have health insurance
排除标准
- •Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment.
- •Blood pressure at initial screening appointment greater than 140/90 mmHg.
- •Presence of any known medical condition confirmed through participant interview
- •Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month)
- •Current smokers or those who have smoked any cigarettes within the past month
- •Pregnant or currently breastfeeding
研究组 & 干预措施
Energy drink
Two 12 oz bottles of energy drink
干预措施: Energy drink (Other)
Placebo
Two 12 oz bottles of placebo drink
干预措施: Placebo drink (Other)
结局指标
主要结局
QTc interval
时间窗: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Maximum change in QTc interval from baseline in each of 2 arm
Central systolic blood pressure
时间窗: Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours
Maximum change in central systolic blood pressure from baseline in each of 2 arm
次要结局
- Heart rate(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- QT interval(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- PR interval(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- QRS duration(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- Augmentation index(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- Central diastolic blood pressure(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)
- Peripheral systolic and diastolic blood pressure(Measurements are obtained at baseline and every 60 minutes after study drink consumption over 4 hours)