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

NCT ID: NCT02023723

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Energy Drink

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

Group Type: EXPERIMENTAL

Energy Drink

Intervention Type: DIETARY_SUPPLEMENT

16oz energy drinks - 2 consumed within 60 minutes

Active Control

Intervention Type: DIETARY_SUPPLEMENT

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

Active Control

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

Group Type: ACTIVE_COMPARATOR

Energy Drink

Intervention Type: DIETARY_SUPPLEMENT

16oz energy drinks - 2 consumed within 60 minutes

Active Control

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Energy Drink

16oz energy drinks - 2 consumed within 60 minutes

Intervention Type: DIETARY_SUPPLEMENT

Active Control

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

David Grant U.S. Air Force Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Fletcher, PhamD

Role: PRINCIPAL_INVESTIGATOR

David Grant AF Medical Center

Locations

David Grant AF Medical Center

Travis Air Force Base, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28446495 (View on PubMed)

Other Identifiers

FDG20130042H

Identifier Type: -

Identifier Source: org_study_id