This study will determine the cardiovascular effects of energy drink consumption in healthy
individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®
Other: energy drink
Other: Moxifloxacin 400mg
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03021616
Ages eligible for Study
18 Years to 40 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
Ages 18-40 years old.
Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1, 8, and 15
In an effort to recruit subjects in general good health, those with the following medical conditions or disease states will be excluded from enrollment:
Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
Hypokalemia or liver abnormalities (AST/ALT abnormality) identified at initial appointment when baseline lab values will be drawn.
Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
Type 1 or 2 diabetes mellitus
Depression, currently receiving treatment (due to possible drug interactions)
Any psychiatric condition or neurological disorder including seizures
History of alcohol or drug abuse in the previous 5 years
Ever been diagnosed or told they have or had renal or hepatic dysfunction
Concurrent use of ANY medication taken in an amount greater than twice a week, to include herbal products or supplements, NOT TO INCLUDE hormonal contraceptives. If less than or equal to 2 days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1, 8 and 15)
All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.
Allergy to any substance in the study design.
Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.
All locations for NCT03021616
United States (1)
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
View full eligibility
Tris trial is registered with FDA with number: NCT03021616. The sponsor of the trial is David Grant U.S. Air Force Medical Center and it is looking for 2 volunteers for the current phase.
Official trial title: Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers: A Randomized, Double Blind, Active-Controlled, Crossover Study
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