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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodynamic Effects of Energy Drink, Electrocardiograph Effects of Energy Drinks

Intervention / Treatment
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* Dietary Supplement: Energy Drink
* Dietary Supplement: Active Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Drink, Electrocardiograph, Hemodynamic