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

Primary Purpose

Dehydration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration focused on measuring dehydration, fluid balance, exercise, heat, body weight, performance

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No medications that influence fluid balance
  • No uncontrolled disease

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Placebo Comparator

Experimental

Arm Label

Water

Placebo

Carbohydrate-electrolyte beverage

Arm Description

Electrolyte- and mineral-free water with exercise intervention

Calorie- and electrolyte-free, sweetened flavored water with exercise intervention

Commercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention

Outcomes

Primary Outcome Measures

Fluid Balance
Fluid balance will be determined by change in body weight during the 120 minutes steady-state exercise bout in the heat.

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2013
Last Updated
September 13, 2022
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01893853
Brief Title
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)
Acronym
APEX
Official Title
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
dehydration, fluid balance, exercise, heat, body weight, performance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water
Arm Type
Other
Arm Description
Electrolyte- and mineral-free water with exercise intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Calorie- and electrolyte-free, sweetened flavored water with exercise intervention
Arm Title
Carbohydrate-electrolyte beverage
Arm Type
Experimental
Arm Description
Commercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fluid Balance
Description
Fluid balance will be determined by change in body weight during the 120 minutes steady-state exercise bout in the heat.
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Rate of fluid uptake in the GI tract
Description
Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.
Time Frame
30 minutes
Title
Amount of carbohydrate oxidized
Description
Carbohydrate oxidation rates will be assessed by indirect calorimetry.
Time Frame
120 minutes
Title
Cardiovascular responses
Description
Heart rate and blood pressure will be assessed during exercise.
Time Frame
120 minutes
Title
Thermoregulatory responses
Description
Body temperatures will be assessed during exercise.
Time Frame
120 minutes
Title
Physical Performance
Description
Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.
Time Frame
30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males aged 18-35 years Healthy (No uncontrolled disease) Exclusion Criteria: No medications that influence fluid balance No uncontrolled disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil M Johannsen, PhD
Organizational Affiliation
Louisiana State University-Department of Kinesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald B Monce, PA-c
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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