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OpenTrials
Completed

NCT Number: NCT02401776

Effect of Caffeine on Heart Function

* 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.

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Key information

Conditions

Fatigue Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Tachycardia

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Environmental and Autonomic Physiology Laboratory; University of Texas at Austin

Austin, Texas, 78721, United States

About this study

This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monster Energy Drink

Dietary Supplement

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

Dietary Supplement

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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