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
Qualifiers
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
Treatments tested in this trial
- Energy Drink A + Placebo Capsule
- Placebo Drink + Moxifloxacin Capsule
- Placebo Drink + Caffeine Capsule
- Placebo Drink + Placebo Capsule
- Energy Drink B
- Control Product + Taurine
- Control Product + Caffeine + Taurine
- Lower Dose Energy Drink A
Treatment groups
3 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov