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NCT Number: NCT07593014

Effects of Creatine and Heat Exposure on Exercise Performance and Body Water Distribution

The goal of this clinical trial is to learn whether creatine supplementation changes how the body adapts to repeated exercise in the heat in healthy recreationally active adults and varsity athletes. The study will also examine whether creatine affects fluid balance, blood volume changes and exercise performance.

The main questions it aims to answer are:

Does creatine supplementation increase plasma volume and total body water during repeated heat exposure more than placebo? Does creatine supplementation improve exercise performance after heat acclimation more than placebo? Does creatine supplementation influence cardiovascular responses to heat stress?

Researchers will compare a creatine supplementation group to a placebo group to determine whether creatine changes the magnitude of heat acclimation adaptations.

Participants will:

Complete baseline measurements of body composition, hydration, blood markers, and exercise performance.

Consume either creatine monohydrate or a placebo supplement daily Complete repeated supervised exercise sessions in a controlled heated environment Undergo repeated assessments of body water, temperature, heart rate, and exercise performance throughout the study

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Key information

Age range

18 year–27 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Heat acclimation (HA) is a physiological adaptation process that occurs following repeated exposure to hot environmental conditions. HA is associated with several beneficial cardiovascular and thermoregulatory adaptations, including plasma volume expansion, improved heat tolerance, lower physiological strain during exercise, and improved exercise performance in hot and temperate environments. However, substantial variability exists in the magnitude and rate of adaptation between individuals.

Creatine monohydrate supplementation is widely used to improve high-intensity exercise performance and is known to increase intracellular water retention within skeletal muscle. Because HA also influences fluid regulation and plasma volume expansion, creatine supplementation may alter fluid distribution and cardiovascular responses during repeated heat exposure. Despite this theoretical interaction, limited research has investigated the combined effects of creatine supplementation and HA on fluid balance and exercise performance.

The purpose of this randomized, double-blind, placebo-controlled trial is to examine whether creatine monohydrate supplementation influences body-fluid distribution, plasma volume expansion, and exercise performance during repeated heat exposure in healthy recreationally active males and varsity athletes.

Participants will complete baseline testing consisting of body composition assessment, body water measurement, capillary blood sampling, resting temperature assessment, and cardiorespiratory and musculoskeletal performance testing using cycle ergometry. Participants will then be randomly assigned to receive either creatine monohydrate or a placebo supplement under double-blind conditions.

The supplementation protocol will include a 7-day loading phase followed by a maintenance phase throughout the remainder of the study. Following supplementation, participants will complete 7 consecutive days of supervised heat exposure consisting of moderate-intensity cycling in a heated environment designed to elevate body temperature and induce heat acclimation adaptations.

Throughout the study, researchers will assess changes in plasma volume, total body water, resting temperature, heart rate responses, and exercise performance. Physiological monitoring will occur during all heat exposure sessions to support participant safety.

The findings from this study may improve understanding of how creatine supplementation influences fluid regulation and adaptation to heat stress. Results may have implications for athletes, physically active individuals, and occupational populations exposed to hot environmental conditions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy biological males between 18 and 27 years of age
  • Recreationally active males and varsity athletes
  • Able to safely participate in moderate-intensity exercise and heat exposure
  • Willing to maintain habitual diet and physical activity throughout the study
  • Willing to refrain from additional dietary supplementation during study participation
  • Able to attend all required laboratory visits and heat exposure sessions
  • Able to provide informed consent

Exclusion criteria

  • History of cardiovascular, metabolic, respiratory, renal, neurological, or heat-related illness
  • Contraindications to exercise testing or heat exposure identified during health screening
  • Current musculoskeletal injury limiting exercise participation
  • Current use of creatine supplementation or inability to complete the required washout period
  • Current use of medications or supplements known to affect hydration, thermoregulation, cardiovascular function, or exercise performance
  • Known allergy or intolerance to creatine monohydrate, maltodextrin, or orange juice
  • Inability to comply with study procedures or supplementation protocol
  • Resting tympanic temperature ≥38.0°C prior to a heat exposure session
  • Participation in another research study that may interfere with this protocol

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

Participants assigned to this intervention will consume micronized creatine monohydrate during a 7-day loading phase at 0.3 g·kg-¹·day-¹ followed by a maintenance dose of 0.03 g·kg-¹·day-¹ during the heat acclimation protocol. Supplements will be dissolved in orange juice and consumed under supervision during laboratory visits. Creatine supplementation will continue throughout the heat acclimation period.

Maltodextrin (Placebo)

Dietary Supplement

Participants will consume maltodextrin matched to creatine supplementation appearance and dosing schedule during the loading and maintenance phases of the study.

Primary outcomes

  1. Plasma Volume Change Following Heat Acclimation and Creatine Supplementation

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    Percent change in plasma volume estimated from capillary blood hematocrit measurements. Following centrifugation, packed red blood cell volume and plasma layers will be measured using a microhematocrit reader, and hematocrit will be expressed as a percentage of total blood volume. Relative changes in blood volume and plasma volume will be inferred from repeated hematological measurements obtained at standardized time points throughout the study.

Secondary outcomes

  1. Change in Total Body Water

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    Total body water measured using bioelectrical impedance analysis (InBody 230).

  2. Change in Intracellular Water

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    Intracellular water estimated using bioelectrical impedance analysis.

  3. Change in Extracellular Water

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    Extracellular water estimated using bioelectrical impedance analysis.

  4. Change in VO₂ Peak

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    VO₂ peak assessed during supramaximal cycling exercise using breath-by-breath metabolic gas analysis.

  5. Change in Musculoskeletal Performance

    Time frame: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

    Musculoskeletal performance assessed during supramaximal cycling exercise using peak and mean power output measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew S Perrotta, Phd

CONTACT

[email protected]

604 679 7172

Benjamin R Tilson, (BSc)

CONTACT

[email protected]

519 819 7732

Sponsors and collaborators

Lead sponsor

University of Windsor

Other

Registry information

Official study title

Creatine Monohydrate Supplementation During Repeated Heat Exposure: Effects on Fluid Balance and Exercise Performance in a Randomized Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

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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