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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 18, 2016
October 1, 2016
1.4 years
May 20, 2014
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Heart rate will be measured as beats per minute.
19 hrs
Blood Pressure will be measured in the brachial artery as mmHG
19 hrs
Study Arms (3)
small dose monster energy drink
EXPERIMENTALThis will be a small dose of monster energy drink
medium dose monster energy drink
EXPERIMENTALThis will be a medium dose of monster energy drink
coffee
ACTIVE COMPARATORThis 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).
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Healthy
- BMI between 24 - 29
You may not qualify if:
- Resting heart rate below 60 bpm
- Resting heart rate above 88 bpm
- Cardiovascular or metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Environmental and Autonomic Physiology Laboratory; University of Texas at Austin
Austin, Texas, 78721, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Brothers, PhD
University of Texas at Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 20, 2014
First Posted
March 30, 2015
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
October 18, 2016
Record last verified: 2016-10