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

This study is currently recruiting participants.
Verified January 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01893853
First received: June 17, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Dehydration
Other: Exercise Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Fluid Balance [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.

  • Amount of carbohydrate oxidized [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Carbohydrate oxidation rates will be assessed by indirect calorimetry.

  • Cardiovascular responses [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Heart rate and blood pressure will be assessed during exercise.

  • Thermoregulatory responses [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Body temperatures will be assessed during exercise.

  • Physical Performance [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Water
Electrolyte- and mineral-free water with exercise intervention
Other: 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
Other: 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
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No medications that influence fluid balance
  • No uncontrolled disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893853

Contacts
Contact: Grace Bella 225-763-3000 clinicaltrials@pbrc.edu
Contact: Neil M Johannsen, PhD 225-578-5314 njohan1@lsu.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Neil M Johannsen, PhD    225-578-5314    njohan1@lsu.edu   
Contact: Pamela Jolivette    225-763-2676    pamela.jolivette@pbrc.edu   
Principal Investigator: Timothy S Church, MD, MPH, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
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
  More Information

Publications:

Responsible Party: Timothy Church, Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01893853     History of Changes
Other Study ID Numbers: PBRC12038
Study First Received: June 17, 2013
Last Updated: January 22, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
dehydration
fluid balance
exercise
heat
body weight
performance

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014