Effect of Caffeine on Heart Function

Not Applicable

Completed

• Conditions: Tachycardia; Fatigue
• Interventions: Dietary Supplement: Monster energy drink; Dietary Supplement: Coffee

• Registration Number: NCT02401776
• Lead Sponsor: University of Texas at Austin

Brief Summary

* 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

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
small dose monster energy drink	Monster energy drink	This will be a small dose of monster energy drink
small dose monster energy drink	Coffee	This will be a small dose of monster energy drink
medium dose monster energy drink	Monster energy drink	This will be a medium dose of monster energy drink
coffee	Coffee	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).
medium dose monster energy drink	Coffee	This will be a medium dose of monster energy drink
coffee	Monster energy drink	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).

Primary Outcome Measures

Name	Time	Method
QT interval will be measured in msec	19 hrs	The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec.

Secondary Outcome Measures

Name	Time	Method
Heart rate will be measured as beats per minute.	19 hrs	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.
Blood Pressure will be measured in the brachial artery as mmHG	19 hrs	The investigators will be measuring artery blood pressure before (baseline) and for 5 hours post beverage consumption. The measurements will be made as mmHg.

Trial Locations

Locations (1)

Environmental and Autonomic Physiology Laboratory; University of Texas at Austin; 🇺🇸 Austin, Texas, United States