The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism

March 18, 2024 updated by: Matthew Brothers, The University of Texas at Arlington
The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Energy drink consumption has gained a lot in popularity and represents one of the most rapidly growing segments of the beverage industry. While regularly discussed in media outlets etc. the cardiovascular effects are not well described or well known. For example, the impacts on various cardiovascular parameters range from improved, decreased, to not impacted at all depending on the source. This can be due to a number of reasons including, study protocol design, study population tested, energy drink product used, volume consumed, etc. Accordingly, this study aims to investigate the impact of acute consumption of a standard commercially available can of energy drink beverage on the following parameters.

  • Arterial blood pressure
  • Heart rate
  • Energy metabolism (oxygen consumption and carbon dioxide production

It is hypothesized that consumption of a 12 oz energy drink will result in modest elevations in arterial blood pressure, heart rate, and energy metabolism relative to when consuming of an equal volume of water.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Arlington, Texas, United States, 76019
        • Recruiting
        • UT Arlington - Science and Engineering Innovation and Research Building
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between ages 18-30
  • Must be free of reported cardiovascular, respiratory, and metabolic diseases.
  • Must be caffeine naïve
  • Must be fasted

Exclusion Criteria:

  • Food allergies
  • pregnant women
  • Breast feeding women
  • Individuals with cardiac, cardiovascular, respiratory, metabolic, and/or neurological disorders
  • taking any prescription vasoactive medications
  • allergies to spandex/lycra

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Energy Drink
A commercially available caffeine drink containing 200 mgs of caffeine.
Dietary supplement: Energy Drink
This is a commercially available energy drink
Placebo Comparator: Water
This will be 12 fl oz of commercially available water .
Other: Water Control
This is a commercially available bottled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood pressure in millimeters of mercury
Time Frame: baseline & 30, 60, 90, 120 min following beverage consumption
blood pressure will be measured on the upper arm using standard procedures that are done in a doctors office.
baseline & 30, 60, 90, 120 min following beverage consumption
Oxygen consumption milliliters per kilogram of body weight per minute
Time Frame: baseline & 30, 60, 90, 120 min following beverage consumption
This will be assessed using a metabolic cart to measure the amount of oxygen that is consumed by the body.
baseline & 30, 60, 90, 120 min following beverage consumption
Heart rate in beats per minute
Time Frame: baseline & 30, 60, 90, 120 min following beverage consumption
Heart will be measured using an electrocardiogram procedures that are done in a doctors office.
baseline & 30, 60, 90, 120 min following beverage consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Arlington

Investigators

  • Principal Investigator: Robert M Brothers, PhD, University of Texas at Arlington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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