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

NCT02023723 | Completed

• 1 other identifier: FDG20130042H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Effects of Energy Drink; Electrocardiograph Effects of Energy Drinks

Keywords

Energy Drink; Electrocardiograph; Hemodynamic

Outcome Measures

Primary Outcomes (1)

• QT/QTc measured on an office ECG

  6 hours over 5 visits

Secondary Outcomes (3)

• Peripheral Blood pressure

  6 hours with 5 visits

• Central blood pressure

  6 hours over 5 visits

• Augmentation Index, pulse wave

  6 hours over 5 visits

Study Arms (2)

Energy Drink

EXPERIMENTAL

16oz original flavor energy drink consume 2 -16oz energy drinks within 60 minutes

Dietary Supplement: Energy Drink; Dietary Supplement: Active Control

Active Control

ACTIVE COMPARATOR

16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes

Dietary Supplement: Energy Drink; Dietary Supplement: Active Control

Interventions

Energy Drink DIETARY_SUPPLEMENT

16oz energy drinks - 2 consumed within 60 minutes

Active Control; Energy Drink

Active Control DIETARY_SUPPLEMENT

16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes

Active Control; Energy Drink

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant AF Medical Center

Travis Air Force Base, California, 94535, United States

Location

Related Publications (1)

• 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.

  PMID: 28446495 DERIVED

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Emily Fletcher, PhamD

  David Grant AF Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

US (1)