Clinical trial NCT02023723: Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
Official title: Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Effects of Energy Drink
Electrocardiograph Effects of Energy Drinks
Keywords: Energy Drink
Electrocardiograph
Hemodynamic
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2013-12-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.


Eligibility criteria: Inclusion Criteria:

* 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 and 8. They must also refrain from consuming additional caffeine or energy drinks during the 24-hour observation time on days 1-2 and 8-9.

Exclusion Criteria:

* 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, 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
* Presence of any known medical condition, confirmed through participant interview. Examples of these are:
* Hypertension
* Thyroid disease
* Type 1 or 2 diabetes mellitus
* Recurrent headaches
* Depression, currently receiving treatment (due to possible drug interactions)
* Any psychiatric condition or neurological disorder
* 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 on a daily basis, to include herbal products or supplements. Daily basis is defined as greater than 2 days per week.
* 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 and 8)
* 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

Primary outcomes:
measure: QT/QTc measured on an office ECG
timeFrame: 6 hours over 5 visits
Secondary outcomes:
measure: Peripheral Blood pressure
timeFrame: 6 hours with 5 visits
measure: Central blood pressure
timeFrame: 6 hours over 5 visits
measure: Augmentation Index, pulse wave
timeFrame: 6 hours over 5 visits
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant AF Medical Center
state: California
Study officials:
affiliation: David Grant AF Medical Center
name: Emily Fletcher, PhamD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448.