NCT07593014

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

Creatine MonohydrateHeat ExposureHeat AcclimationShort Term Heat AcclimationPlasma VolumeFluid BalanceBody Fluid CompartmentsWingate TestVO2 MaxCardiorespiratory PerformanceMusculoskeletal Performance

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

EXPERIMENTAL

Participants 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.

Dietary Supplement: Creatine Monohydrate

Placebo + Heat Exposure

PLACEBO COMPARATOR

Participants 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.

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Creatine MonohydrateDIETARY_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.

Creatine Monohydrate + Heat Exposure
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.

Placebo + Heat Exposure

Eligibility Criteria

Age18 Years - 27 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

    BACKGROUND
  • Mack, 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

    BACKGROUND
  • Periard 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: 25943654BACKGROUND
  • Lorenzo 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: 20724560BACKGROUND
  • Kreider 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: 28615996BACKGROUND
  • Dill 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

Creatinemaltodextrin

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Andrew S Perrotta, Phd

CONTACT

Benjamin R Tilson, (BSc)

CONTACT

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