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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Effects of Energy Drink; Electrocardiograph Effects of Energy Drinks
• Intervention / Treatment: Dietary supplement: Energy Drink; Dietary supplement: Active Control

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Travis Air Force Base, California, United States, 94535
      • David Grant AF Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energy Drink; 16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes	Dietary supplement: Energy Drink; 16oz energy drinks - 2 consumed within 60 minutes; Dietary supplement: Active Control; 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes
Active Comparator: Active Control; 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes	Dietary supplement: Energy Drink; 16oz energy drinks - 2 consumed within 60 minutes; Dietary supplement: Active Control; 16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QT/QTc measured on an office ECG	6 hours over 5 visits

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: David Grant U.S. Air Force Medical Center
• Investigators: Principal Investigator: Emily Fletcher, PhamD, David Grant AF Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 24, 2013
• First Submitted That Met QC Criteria: December 24, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Hemodynamic; Energy Drink; Electrocardiograph
• Other Study ID Numbers: FDG20130042H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No