Effect of Caffeine on Heart Function

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

• 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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Tachycardia
• Intervention / Treatment: Dietary supplement: Monster Energy Drink; Dietary supplement: Monster Energy Drink; Dietary supplement: Coffee; Dietary supplement: Monster energy drink

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78721
      • Environmental and Autonomic Physiology Laboratory; University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: small dose monster energy drink; This will be a small dose of monster energy drink	Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Coffee; 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).
Experimental: medium dose monster energy drink; This will be a medium dose of monster energy drink	Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Coffee; 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).
Active Comparator: 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).	Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Monster Energy Drink; 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).; Dietary supplement: Coffee; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Robert M Brothers, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: blood pressure; caffeine; heart rate; energy drink
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: 2014-03-0069