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Effect of Caffeine on Heart Function

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ClinicalTrials.gov Identifier: NCT02401776
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Robert M. Brothers, 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.


Condition or disease Intervention/treatment Phase
Fatigue Tachycardia Dietary Supplement: Monster Energy Drink Dietary Supplement: Monster energy drink Dietary Supplement: Coffee Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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
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).

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
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).

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
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).

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).




Primary Outcome Measures :
  1. QT interval will be measured in msec [ Time Frame: 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 :
  1. Heart rate will be measured as beats per minute. [ Time Frame: 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.

  2. Blood Pressure will be measured in the brachial artery as mmHG [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401776


Locations
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United States, Texas
Environmental and Autonomic Physiology Laboratory; University of Texas at Austin
Austin, Texas, United States, 78721
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Robert M Brothers, PhD University of Texas at Austin

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Responsible Party: Robert M. Brothers, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02401776     History of Changes
Other Study ID Numbers: 2014-03-0069
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Robert M. Brothers, University of Texas at Austin:
heart rate
blood pressure
caffeine
energy drink

Additional relevant MeSH terms:
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Fatigue
Tachycardia
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents