Effects of Energy Drinks on Cardiovascular Endpoints
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of the Pacific
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Energy Drink A + Placebo Capsule
Dietary supplement1000 mL caffeine- and taurine-containing commercially available beverage (Formula A) consumed with placebo capsule
Placebo Drink + Moxifloxacin Capsule
DrugPlacebo drink with 400 mg moxifloxacin capsule
Placebo Drink + Caffeine Capsule
Dietary supplementPlacebo drink with 320 mg caffeine capsule
Placebo Drink + Placebo Capsule
Other interventionPlacebo drink with placebo capsule
Energy Drink B
Dietary supplement568 mL caffeine- and taurine-containing commercially available beverage (Formula B)
Control Product + Taurine
Dietary supplementControl product with 4000 mg taurine powder
Control Product + Caffeine + Taurine
Dietary supplementControl product with 320 mg caffeine + 4000 mg taurine powder
Lower Dose Energy Drink A
Dietary supplement591 mL caffeine- and taurine-containing commercially available beverage (Formula A)
Treatment groups
3 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Phase A: Energy Drink A + PlaceboExperimental treatment 1 intervention
Group B: Phase A: Placebo Drink + MoxifloxacinActive comparator 1 intervention
Group C: Phase A: Placebo Drink + CaffeineActive comparator 1 intervention
Group D: Phase A: Placebo Drink + Placebo CapsulePlacebo comparator 1 intervention
Group E: Phase B: Energy Drink BExperimental treatment 1 intervention
Group F: Phase B: Control + TaurineExperimental treatment 1 intervention
Group G: Phase B: Control + Caffeine + TaurineExperimental treatment 1 intervention
Group H: Phase B: Lower Dose Energy Drink AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change 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-interventionSecondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
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Source ClinicalTrials.gov