Cardiovascular Effects of Energy Drinks in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of this study is to elucidate the physiological/cardiovascular response to an energy drink consumption as compared to a control drink both at rest and during stressful conditions in healthy adults.
详细描述
The study will collect data to determine the hemodynamic changes (magnitude of heart rate and blood pressure response) in healthy adults after consumption of an energy drink and compare these responses to those after a control drink. Study will be performed at a hospital Clinical Research Unit on two separate days; minimum 24 hours and maximum 1 month apart. Participants will be fasting 4 hours prior to the study and will be asked to abstain from caffeine and alcohol for at least 24 hours prior to initiation of this study. Baseline measurements will be obtained during and after 10 minutes of rest. After the end of baseline recordings, the subjects will be given up to 500 ml (1 can, approximately 16 fluid ounces) of caffeinated energy drink or a control drink, based on randomization. They will have 30 minutes to drink it. The second set of measurements will be obtained after an energy drink or control drink intake, using exactly the same protocol as at baseline. The second study visit, participant will receive the alternate intervention.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older
- •Healthy subjects without known cardiovascular disease and thyroid disease
- •Subjects who are on no medications (except oral contraceptive pill)
- •Nonsmokers
- •No prior history of caffeine sensitivity or allergy
排除标准
- •Subjects with known cardiovascular and/or thyroid disease
- •Subjects currently taking medications other than oral contraceptive pill
- •Prior history of caffeine sensitivity or allergy
- •Pregnancy
研究组 & 干预措施
Energy drink first, then placebo drink
Participants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.
干预措施: Energy Drink (Other)
Energy drink first, then placebo drink
Participants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.
干预措施: Placebo Drink (Other)
Placebo drink first, then energy drink
Participants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.
干预措施: Energy Drink (Other)
Placebo drink first, then energy drink
Participants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.
干预措施: Placebo Drink (Other)
结局指标
主要结局
Change in blood pressure
时间窗: Baseline, 30 minutes after consumption
次要结局
- Change in Plasma Norepinephrine(Baseline, 30 minutes after consumption)
- Change in heart rate(Baseline, 30 minutes after consumption)
研究者
Anna Svatikova
Assistant Professor of Medicine
Mayo Clinic