Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

11 de maio de 2026 atualizado por: 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

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

25

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comparador de Placebo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Plasma Volume Change Following Heat Acclimation and Creatine Supplementation
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Total Body Water
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de julho de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

30 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever