Status:
COMPLETED
Post-Exercise Cardiovascular Responses Following Energy Drink Consumption
Lead Sponsor:
David Grant U.S. Air Force Medical Center
Conditions:
QTc Interval
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of consuming an original flavor energy drink on electrocardiographic (ECG) and hemodynamic responses during and after exercise in healthy subjects...
Detailed Description
The study will employ a double-blinded, randomized, crossover design to evaluate the cardiovascular (CV) effects of an energy drink during post-exercise recovery. Subjects who express interest in the ...
Eligibility Criteria
Inclusion
- Participants at David Grant Medical Center (DGMC): Healthy male and female, active duty military service members or Department of Defense (DoD) beneficiaries, who are eligible to receive care at DGMC. Participants at CSUS: Healthy male and female CSUS students.
- Ages 18-40 years old
- Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days.
Exclusion
- 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(msec). 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 130/80
- 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 five 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 two 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).
- 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.
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03418077
Start Date
May 7 2018
End Date
May 31 2019
Last Update
April 17 2020
Active Locations (1)
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1
USAF David Grant Medical Center
Travis Air Force Base, California, United States, 94535