Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers

Not Applicable

Completed

• Conditions: Electrocardiograph Effects of Energy Drinks; Hemodynamic Effects of Energy Drink
• Interventions: Dietary Supplement: Energy Drink; Dietary Supplement: Active Control

• Registration Number: NCT02023723
• Lead Sponsor: David Grant U.S. Air Force Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-30
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Control	Active Control	16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes
Energy Drink	Energy Drink	16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes
Energy Drink	Active Control	16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes
Active Control	Energy Drink	16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes

Primary Outcome Measures

Name	Time	Method
QT/QTc measured on an office ECG	6 hours over 5 visits

Secondary Outcome Measures

Name	Time	Method
Central blood pressure	6 hours over 5 visits	utilizing an applanation tonometry device
Peripheral Blood pressure	6 hours with 5 visits	systolic and diastolic
Augmentation Index, pulse wave	6 hours over 5 visits

Trial Locations

Locations (1)

David Grant AF Medical Center; 🇺🇸 Travis Air Force Base, California, United States