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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
3
1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
Placebo drink with 400 mg moxifloxacin capsule
Placebo drink with 320 mg caffeine capsule
University of the Pacific
Stockton, California, United States
RECRUITINGChange from Baseline in Corrected QT Interval (QTc) in Milliseconds (ms)
QTc interval will be calculated using both Bazett's and Fridericia's correction formulas assessed via 12-lead ECG.
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in QT Interval in Milliseconds (ms)
As assessed via 12-lead ECG
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in RR Interval in Milliseconds (ms)
As assessed via 12-lead ECG
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in PR Interval in Milliseconds (ms)
As assessed via 12-lead ECG
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in QRS Duration in Milliseconds (ms)
As assessed via 12-lead ECG
Time frame: 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)
Assessed via a non-invasive automated blood pressure device
Time frame: 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)
Assessed via a non-invasive automated blood pressure device
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Placebo drink with placebo capsule
568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
Control product with 4000 mg taurine powder
Control product with 320 mg caffeine + 4000 mg taurine powder
591 mL caffeine- and taurine-containing commercially available beverage (Formula A)
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Heart Rate (HR) in Beats Per Minute (BPM)
Assessed via non-invasive bioimpedance monitoring and/or 12-lead ECG
Time frame: 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)
Assessed via non-invasive bioimpedance monitoring during Phase A only
Time frame: 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)
Assessed via non-invasive bioimpedance monitoring during Phase A only
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Interstitial Glucose Level (mg/dL)
Assessed via a continuously worn arm sensor (Continuous Glucose Monitor, CGM) during Phase A only
Time frame: Baseline, 30, 60, 90, 120, 150, 180, and 240 minutes post-intervention
Change from Baseline in Reactive Hyperemia Index (RHI)
A non-invasive, unitless measure of endothelial function assessed via peripheral arterial tonometry (EndoPAT) during Phase A only
Time frame: Baseline, 120, and 240 minutes post-intervention