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Effect of Caffeine on Heart Function

Primary Purpose

Fatigue, Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monster Energy Drink
Monster energy drink
Monster Energy Drink
Coffee
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue focused on measuring heart rate, blood pressure, caffeine, energy drink

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Environmental and Autonomic Physiology Laboratory; University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

small dose monster energy drink

medium dose monster energy drink

coffee

Arm Description

This will be a small dose of monster energy drink

This will be a medium dose of 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 20, 2014
Last Updated
October 17, 2016
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02401776
Brief Title
Effect of Caffeine on Heart Function
Official Title
An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Tachycardia
Keywords
heart rate, blood pressure, caffeine, energy drink

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
small dose monster energy drink
Arm Type
Experimental
Arm Description
This will be a small dose of monster energy drink
Arm Title
medium dose monster energy drink
Arm Type
Experimental
Arm Description
This will be a medium dose of monster energy drink
Arm Title
coffee
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Monster Energy Drink
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Monster energy drink
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Monster Energy Drink
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Coffee
Intervention Description
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).
Primary Outcome Measure Information:
Title
QT interval will be measured in msec
Description
The investigators will be measuring cardiac QT interval before (baseline) and for 5 hours post beverage consumption. The measurements will be made in msec.
Time Frame
19 hrs
Secondary Outcome Measure Information:
Title
Heart rate will be measured as beats per minute.
Description
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.
Time Frame
19 hrs
Title
Blood Pressure will be measured in the brachial artery as mmHG
Description
The investigators will be measuring artery blood pressure before (baseline) and for 5 hours post beverage consumption. The measurements will be made as mmHg.
Time Frame
19 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Brothers, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental and Autonomic Physiology Laboratory; University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78721
Country
United States

12. IPD Sharing Statement

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Effect of Caffeine on Heart Function

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