Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

11. maj 2026 opdateret af: Dr. Andrew S. Perrotta, University of Windsor

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

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

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Creatine Monohydrate + Heat Exposure
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.
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.
Placebo komparator: Placebo + Heat Exposure
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.
Participants will consume maltodextrin matched to creatine supplementation appearance and dosing schedule during the loading and maintenance phases of the study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma Volume Change Following Heat Acclimation and Creatine Supplementation
Tidsramme: 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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Body Water
Tidsramme: 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).
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Intracellular Water
Tidsramme: 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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Extracellular Water
Tidsramme: 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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in VO₂ Peak
Tidsramme: 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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
Change in Musculoskeletal Performance
Tidsramme: 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.
Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. august 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Creatine Monohydrate

Abonner