Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study) (APEX)

September 13, 2022 updated by: Pennington Biomedical Research Center
The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage intake promotes fluid balance during exercise in the heat compared with water or placebo intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exercise in the heat has large effects on cardiovascular strain, the ability to regulate core body temperature, and performance because of an increase in the reliance on body fluid distribution to the skin to maintain adequate sweat rates and heat dissipation. Carbohydrate-electrolyte beverage intake during exercise in the heat may improve fluid balance and subsequent physical performance.

The participants will be assigned each arm in a randomized, counterbalanced, cross-over fashion separated by at least 2 weeks. Participants will be placed in a heated environment for the duration of the exercise intervention.

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males aged 18-35 years
  • Healthy (No uncontrolled disease)

Exclusion Criteria:

  • No medications that influence fluid balance
  • No uncontrolled disease

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Water
Electrolyte- and mineral-free water with exercise intervention
Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.
Placebo Comparator: Placebo
Calorie- and electrolyte-free, sweetened flavored water with exercise intervention
Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.
Experimental: Carbohydrate-electrolyte beverage
Commercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention
Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid Balance
Time Frame: 120 minutes
Fluid balance will be determined by change in body weight during the 120 minutes steady-state exercise bout in the heat.
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of fluid uptake in the GI tract
Time Frame: 30 minutes
Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.
30 minutes
Amount of carbohydrate oxidized
Time Frame: 120 minutes
Carbohydrate oxidation rates will be assessed by indirect calorimetry.
120 minutes
Cardiovascular responses
Time Frame: 120 minutes
Heart rate and blood pressure will be assessed during exercise.
120 minutes
Thermoregulatory responses
Time Frame: 120 minutes
Body temperatures will be assessed during exercise.
120 minutes
Physical Performance
Time Frame: 30 minutes
Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.
30 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Timothy S Church, MD, MPH, PhD, Pennington Biomedical Research Center
  • Study Chair: Neil M Johannsen, PhD, Louisiana State University-Department of Kinesiology
  • Study Chair: Ronald B Monce, PA-c, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

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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