Effect of Caffeine on Heart Function

NCT ID: NCT02401776

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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* 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

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

Conditions

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Fatigue Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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small dose monster energy drink

This will be a small dose of monster energy drink

Group Type EXPERIMENTAL

Monster Energy Drink

Intervention Type 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).

Monster energy drink

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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).

medium dose monster energy drink

This will be a medium dose of monster energy drink

Group Type EXPERIMENTAL

Monster Energy Drink

Intervention Type 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).

Monster energy drink

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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).

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).

Group Type ACTIVE_COMPARATOR

Monster Energy Drink

Intervention Type 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).

Monster energy drink

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Robert M. Brothers

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert M Brothers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Environmental and Autonomic Physiology Laboratory; University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2014-03-0069

Identifier Type: -

Identifier Source: org_study_id

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