Impact of Energy Drinks on Cardiovascular Endpoints

Study Overview
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Brief Summary
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Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects. Study design: Double blind, placebo controlled, cross-over Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions. Intervention: Energy drink or Placebo Primary outcome: Change in office systolic blood pressure

Official Title
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Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Energy Drink
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers between ages 18-40 years ONLY as needed use of ibuprofen or acetamenophen Active duty military DoD beneficiary or Civilian Government Employees Exclusion Criteria: No other co-morbid conditions No active prescription or OTC drug use Not pregnant or planning to become pregnant during study participation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Drink<br>Energy drink, 2 oz twice daily for 7 days | Dietary Supplement: Energy Drink<br>* Energy drink, 2oz twice daily for 7 days<br>|
| Placebo Comparator: Placebo<br>Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days | Other: Placebo<br>* Water, lime juice and cherry flavoring<br>* Other names: Water, lime juice and cherry flavoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic Blood Pressure | SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | At baseline and 7 days post energy drink and placebo consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office DBP After a Single Energy Shot and After Chronic Consumption | DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | At baseline and 7 days post energy drink and placebo consumption | 
| Max Heart Rate After a Single Shot and After Chronic Consumption | Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption | 
| Max PR-interval After a Single Shot and After Chronic Consumption | Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption | 
| Max QRS Duration After a Single Shot and After Chronic Consumption | Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption | 
| Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption | 
| Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption |