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Completed

NCT Number: NCT01893853

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

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.

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Key information

Conditions

Dehydration Behavior Body Weight Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No medications that influence fluid balance
  • No uncontrolled disease

Treatment and study plan

Exercise intervention

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Amount of carbohydrate oxidized

    Time frame: 120 minutes

    Carbohydrate oxidation rates will be assessed by indirect calorimetry.

  3. Cardiovascular responses

    Time frame: 120 minutes

    Heart rate and blood pressure will be assessed during exercise.

  4. Thermoregulatory responses

    Time frame: 120 minutes

    Body temperatures will be assessed during exercise.

  5. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: APEX

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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