Evaluation of Energy Drinks on Electrocardiographic Parameters: A Randomized, Double Blind, Controlled, Crossover, Proof-of-concept Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms)
研究概览
简要总结
This is a clinical trial looking at the impact of energy drinks on heart related parameters. The study will enroll 3 participants who will be exposed to 8 different interventions.
详细描述
This study is a randomized, double-blind, controlled, crossover, proof-of-concept trial designed to examine how energy drinks affect heart rhythm and other health measures in healthy adults aged 18 to 40. This study investigates the cardiovascular safety of energy drinks by examining their effects on electrocardiographic parameters, with a specific focus on the QTc interval.
The protocol consists of two phases conducted with 3 healthy volunteers. Phase A (Visits 1-4) evaluates four interventions: 1) energy drink A 2) moxifloxacin 3) caffeine 4) placebo.
Phase B (Visits 5-8) evaluates four interventions: 1) energy drink B 2) taurine 3) caffeine + taurine 4) lower dose energy drink A.
After an overnight fast participants will consume the study intervention within a 30 minute period. Over the next 4 hours, the electrocardiogram, blood pressure, hemodynamics, glucose, endothelial function, and side effects will be monitored. Participants maintain minimal physical activity during this period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 of age
- •Female participants of child-bearing potential must have a negative pregnancy test at the baseline visit
- •Participants must be willing to refrain from caffeine and alcohol use 72 hours prior to sessions on study days
- •Participants must be willing and able to: (1.) Consume up to 1 liter of fluid within a 30-minute period per visit (2.) Swallow a single large capsule per visit
- •Participants must be willing to fast 10 hours prior to sessions on study days (only water is allowed during the fasting and active study period)
- •Participants must have active health insurance throughout the duration of the study
排除标准
- •Have a corrected QT (QTc) interval greater than 450 milliseconds (ms) for males or greater than 470 milliseconds (ms) for females, determined during the baseline visit
- •Presence of any known medical condition, confirmed through participant interview. Examples of these include but not limited to: Dyslipidemia, Thyroid disease, Diabetes, Recurrent headache, Any psychiatric condition or neurological disorder, History of alcohol or drug abuse, Past diagnosis or history of renal insufficiencies, Hepatic dysfunction, Electrolyte imbalances requiring hospitalization
- •Presence of any known heart/cardiac diseases or conditions such as: Atrial Fibrillation, History of stroke or heart attack, Hypertension, Heart Failure, Vascular Disease, Family history/Active Long QT Syndrome, Coronary artery disease, Cardiomyopathy, Valvular heart disease, Ventricular arrhythmia, Congenital heart defect, Pericardial disease, Myocarditis
- •Study physician recommendation for participant to not be enrolled.
- •Are underweight (BMI<18.5 kg/m2, CDC 2024), have poor eating habits resulting in poor weight control, or have any factors that will put the participant at risk from fasting.
- •Have any contraindications to the use of moxifloxacin, including a past medical history of myasthenia gravis, QT prolongation, or hypersensitivities and allergic reactions to moxifloxacin or any other fluoroquinolone antibiotics
- •Pre-existing risk to tendinitis and tendon rupture, peripheral neuropathy, or central nervous system side effects
- •Concurrent use of ANY medication taken daily including herbal products or supplements (daily basis is defined as greater than 2 days per week)
- •Self-reported allergy to taurine
- •Self-reported allergy to nuts (peanuts, pecans, cashews, etc.)
- •Self-reported allergic reaction to the adhesive pads (electrodes, continuous glucose monitors, etc.)
- •Fear of needle puncture
- •Smokers using cigarettes, vaporized nicotine, or marijuana products currently or within the past month
- •Current usage of any nicotine or tobacco products including but not limited to intranasal, sublingual, oral, or transdermal dosage forms
- •Currently pregnant or breastfeeding
- •Have a positive pregnancy test during the baseline visit
- •Are currently enrolled in any other clinical study or have participated in another study within the last 30 days
- •Non-English speaking/reading individuals will be excluded due to the unavailability of medically qualified translators throughout all study procedures
- •If the candidate does not sign the informed consent document
研究组 & 干预措施
Phase A: Energy Drink A + Placebo
Energy Drink A (320 mg caffeine) consumed with placebo capsule
干预措施: Energy Drink A + Placebo Capsule (Dietary Supplement)
Phase A: Placebo Drink + Moxifloxacin
Placebo drink with 400 mg moxifloxacin capsule
干预措施: Placebo Drink + Moxifloxacin Capsule (Drug)
Phase A: Placebo Drink + Caffeine
Placebo drink with 320 mg caffeine capsule
干预措施: Placebo Drink + Caffeine Capsule (Dietary Supplement)
Phase A: Placebo Drink + Placebo Capsule
Placebo drink with Placebo capsule
干预措施: Placebo Drink + Placebo Capsule (Other)
Phase B: Energy Drink B
Energy Drink B (320 mg caffeine)
干预措施: Energy Drink B (Dietary Supplement)
Phase B: Control + Taurine
Control product with 4000 mg taurine powder
干预措施: Control Product + Taurine (Dietary Supplement)
Phase B: Control + Caffeine + Taurine
Control product with 320 mg caffeine + 4000 mg taurine powder
干预措施: Control Product + Caffeine + Taurine (Dietary Supplement)
Phase B: Lower Dose Energy Drink A
Energy Drink A (189 mg caffeine)
干预措施: Lower Dose Energy Drink A (Dietary Supplement)
结局指标
主要结局
Change from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms)
时间窗: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
QTc interval will be calculated using both Bazett's and Fridericia's correction formulas assessed via 12-lead ECG.
次要结局
- Change from Baseline in QT Interval in Milliseconds (ms)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in RR Interval in Milliseconds (ms)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in PR Interval in Milliseconds (ms)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in QRS Duration in Milliseconds (ms)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Systolic Blood Pressure (SBP) in Millimeters of Mercury (mmHg)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Diastolic Blood Pressure (DBP) in Millimeters of Mercury (mmHg)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Heart Rate (HR) in Beats Per Minute (BPM)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Cardiac Output (CO) in Liters Per Minute (L/min)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Stroke Volume (SV) in Milliliters Per Beat (mL/beat)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Interstitial Glucose Level (mg/dL)(Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention)
- Change from Baseline in Reactive Hyperemia Index (RHI)(Baseline, 120, and 240 minutes post-intervention)
研究者
Sachin Shah
Professor of Pharmacy Practice
University of the Pacific