Impact of Energy Drink Brands on Heart Rhythm

Study Overview
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Brief Summary
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To assess the cardiac effects of energy drink brands in healthy volunteers

Detailed Description
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Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.

Official Title
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Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial

Conditions
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Electrical Alternation of Heart, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Energy Drink Brand 1
* Dietary Supplement: Energy Drink Brand 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female adults 18 - 40 years old Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15 Exclusion Criteria: Presence of any known medical condition confirmed through participant interview QTc interval greater than 450 milliseconds (ms). Blood pressure greater than 140/90 mmHg. Current smokers Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives). Pregnant or currently breast-feeding

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 Brand 1<br>Two 16-oz bottles of Energy Drink Brand 1 | Dietary Supplement: Energy Drink Brand 1<br>* Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes<br>|
| Experimental: Energy Drink Brand 2<br>Two 16-oz bottles of Energy Drink Brand 2 | Dietary Supplement: Energy Drink Brand 2<br>* Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes<br>|
| Placebo Comparator: Placebo<br>Two 16-oz bottles that each contain 390 ml of carbonated water, 20 ml of reconstituted lime juice, and 70 ml of cherry flavoring | Other: Placebo<br>* Lime juice, water, and cherry flavoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected QT (QTc) Interval | Electrocardiograph (ECG) Parameters | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT | Electrocardiograph (ECG) Parameters | 4 hours | 
| PR | Electrocardiograph (ECG)Parameters | 4 hours | 
| QRS | Electrocardiograph (ECG) Parameters | 4 hours | 
| Heart Rate (HR) | Electrocardiograph (ECG) Parameters | 4 hours | 
| Central blood pressure | Hemodynamic Parameters | 4 hours | 
| Peripheral blood pressure | Hemodynamic Parameters | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Blood Pressure, Energy Drinks