Effect of Caffeine on Heart Function

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401776
• Other study ID #: 2014-03-0069
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: October 17, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatigue
• Tachycardia

Intervention

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).
• Monster energy drink
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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Environmental and Autonomic Physiology Laboratory; University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No