Effects of Creatine and Heat Exposure on Exercise Performance and Body Water Distribution
Creatine Monohydrate Supplementation During Repeated Heat Exposure: Effects on Fluid Balance and Exercise Performance in a Randomized Double-Blind, Placebo-Controlled Trial
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 18, 2026
CompletedStudy Start
First participant enrolled
July 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
Study Completion
Last participant's last visit for all outcomes
August 30, 2027
May 18, 2026
May 1, 2026
9 months
May 11, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Volume Change Following Heat Acclimation and Creatine Supplementation
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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Secondary Outcomes (5)
Change in Total Body Water
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Intracellular Water
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Extracellular Water
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in VO₂ Peak
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Musculoskeletal Performance
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Study Arms (2)
Creatine Monohydrate + Heat Exposure
EXPERIMENTALParticipants assigned to this arm will complete a 7-day creatine monohydrate loading phase followed by daily maintenance supplementation during a 7-day heat acclimation protocol. Participants will complete daily supervised heat exposure sessions consisting of cycling exercise in a controlled hot environment.
Placebo + Heat Exposure
PLACEBO COMPARATORParticipants assigned to this arm will consume a placebo supplement (maltodextrin) matched in appearance and dosing schedule to the creatine condition during a 7-day heat acclimation protocol. Participants will complete daily supervised heat exposure sessions consisting of cycling exercise in a controlled hot environment.
Interventions
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.
Participants will consume maltodextrin matched to creatine supplementation appearance and dosing schedule during the loading and maintenance phases of the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Wenger CB (2003). Human adaptation to hot environments. In K. B. Pandolf, M. N. Sawka, & R. R. Gonzalez (Eds.), Human performance physiology and environmental medicine at terrestrial extremes (pp. 379-438). Benchmark Press.
BACKGROUNDMack, G.W. and Nadel, E.R. (1994), Body Fluid Balance During Heat Stress in Humans. Comprehensive Physiology, 1994: 187-214. https://doi.org/10.1002/j.2040-4603.1994.tb01156.x
BACKGROUNDPeriard JD, Racinais S, Sawka MN. Adaptations and mechanisms of human heat acclimation: Applications for competitive athletes and sports. Scand J Med Sci Sports. 2015 Jun;25 Suppl 1:20-38. doi: 10.1111/sms.12408.
PMID: 25943654BACKGROUNDLorenzo S, Halliwill JR, Sawka MN, Minson CT. Heat acclimation improves exercise performance. J Appl Physiol (1985). 2010 Oct;109(4):1140-7. doi: 10.1152/japplphysiol.00495.2010. Epub 2010 Aug 19.
PMID: 20724560BACKGROUNDKreider RB, Kalman DS, Antonio J, Ziegenfuss TN, Wildman R, Collins R, Candow DG, Kleiner SM, Almada AL, Lopez HL. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine. J Int Soc Sports Nutr. 2017 Jun 13;14:18. doi: 10.1186/s12970-017-0173-z. eCollection 2017.
PMID: 28615996BACKGROUNDDill DB, Costill DL. Calculation of percentage changes in volumes of blood, plasma, and red cells in dehydration. J Appl Physiol. 1974 Aug;37(2):247-8. doi: 10.1152/jappl.1974.37.2.247. No abstract available.
PMID: 4850854BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This study uses a double-blind design. Participants and investigators involved in data collection and testing procedures will be blinded to supplement allocation. Creatine monohydrate and placebo supplements will be prepared in identical containers and mixed with orange juice to maintain blinding. Group allocation codes will remain concealed until completion of data collection and primary analyses.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Kinesiology, University of Windsor
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 18, 2026
Study Start (Estimated)
July 30, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share