NCT06330649

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 12, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Energy metabolismArterial blood pressureheart rate

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Energy Drink

EXPERIMENTAL

A commercially available caffeine drink containing 200 mgs of caffeine.

Dietary Supplement: Energy Drink

Water

PLACEBO COMPARATOR

This will be 12 fl oz of commercially available water .

Other: Water Control

Interventions

Energy DrinkDIETARY_SUPPLEMENT

This is a commercially available energy drink

Energy Drink

This is a commercially available bottled water

Water

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Interventions

Energy Drinks

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Robert M Brothers, PhD

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Individuals will be randomly assigned to either an experimental or a control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 26, 2024

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to share IPD.

Locations