Clinical trial NCT01893853: Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)
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
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Keywords: dehydration
fluid balance
exercise
heat
body weight
performance
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No medications that influence fluid balance
* No uncontrolled disease

Primary outcomes:
measure: Fluid Balance
timeFrame: 120 minutes
Secondary outcomes:
measure: Rate of fluid uptake in the GI tract
timeFrame: 30 minutes
measure: Amount of carbohydrate oxidized
timeFrame: 120 minutes
measure: Cardiovascular responses
timeFrame: 120 minutes
measure: Thermoregulatory responses
timeFrame: 120 minutes
measure: Physical Performance
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Timothy S Church, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University-Department of Kinesiology
name: Neil M Johannsen, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Ronald B Monce, PA-c
role: STUDY_CHAIR
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