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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06330649
Other study ID # 2024-0095
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date August 31, 2025

Study information

Verified date March 2024
Source The University of Texas at Arlington
Contact Robert M Brothers, PhD
Phone 817-272-3288
Email matthew.brothers@uta.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Energy Drink
This is a commercially available energy drink
Other:
Water Control
This is a commercially available bottled water

Locations

Country Name City State
United States UT Arlington - Science and Engineering Innovation and Research Building Arlington Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peripheral blood pressure in millimeters of mercury 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
Primary Oxygen consumption milliliters per kilogram of body weight per minute 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
Primary Heart rate in beats per minute Heart will be measured using an electrocardiogram procedures that are done in a doctors office. baseline & 30, 60, 90, 120 min following beverage consumption
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