Effect of Caffeine on Heart Function

Study Overview
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Brief Summary
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The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG. The secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects). To place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: Starbuck's K-cup Breakfast Blend.

Detailed Description
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This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.

Official Title
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An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee

Conditions
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Fatigue, Tachycardia

Intervention / Treatment
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* Dietary Supplement: Monster Energy Drink
* Dietary Supplement: Monster energy drink
* Dietary Supplement: Monster Energy Drink
* Dietary Supplement: Coffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy BMI between 24 - 29 Exclusion Criteria: Resting heart rate below 60 bpm Resting heart rate above 88 bpm Cardiovascular or metabolic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: small dose monster energy drink<br>This will be a small dose of monster energy drink | Dietary Supplement: Monster Energy Drink<br>* Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster energy drink<br>* Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster Energy Drink<br>* Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Coffee<br>* Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).<br>|
| Experimental: medium dose monster energy drink<br>This will be a medium dose of monster energy drink | Dietary Supplement: Monster Energy Drink<br>* Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster energy drink<br>* Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster Energy Drink<br>* Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Coffee<br>* Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).<br>|
| Active Comparator: coffee<br>This will be a coffee group and will drink Starbuck's K-cup Breakfast Blend. This will be mixed according to packing instructions and will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 11 ounce cup of coffee for a person weighing 75 kg). | Dietary Supplement: Monster Energy Drink<br>* Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster energy drink<br>* Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Monster Energy Drink<br>* Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).<br>Dietary Supplement: Coffee<br>* Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT interval will be measured in msec | The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec. | 19 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate will be measured as beats per minute. | The investigators will be measuring cardiac heart rate before (baseline) and for 5 hours post beverage consumption. The measurements will be made as beats per minute. | 19 hrs | 
| Blood Pressure will be measured in the brachial artery as mmHG | The investigators will be measuring artery blood pressure before (baseline) and for 5 hours post beverage consumption. The measurements will be made as mmHg. | 19 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rate, blood pressure, caffeine, energy drink