- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07593014
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
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Andrew S Perrotta, Phd
- Numer telefonu: 604 679 7172
- E-mail: Andrew.Perrotta@uwindsor.ca
Kopia zapasowa kontaktu do badania
- Nazwa: Benjamin R Tilson, (BSc)
- Numer telefonu: 519 819 7732
- E-mail: tilsonb@uwindsor.ca
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Komparator 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.
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Participants will consume maltodextrin matched to creatine supplementation appearance and dosing schedule during the loading and maintenance phases of the study.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Plasma Volume Change Following Heat Acclimation and Creatine Supplementation
Ramy czasowe: 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.
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Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Total Body Water
Ramy czasowe: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
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Total body water measured using bioelectrical impedance analysis (InBody 230).
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Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
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Change in Intracellular Water
Ramy czasowe: 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.
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Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
|
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Change in Extracellular Water
Ramy czasowe: Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
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Extracellular water estimated using bioelectrical impedance analysis.
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Measured at baseline (pre-supplementation), after 7 days of creatine/placebo loading, and after 7 days of heat acclimation.
|
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Change in VO₂ Peak
Ramy czasowe: 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.
|
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Change in Musculoskeletal Performance
Ramy czasowe: 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.
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- #26-057
Plan dla danych uczestnika indywidualnego (IPD)
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Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Creatine Monohydrate
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Eli Lilly and CompanyZakończonyGlejaka wielopostaciowegoStany Zjednoczone, Niemcy, Hiszpania, Belgia, Holandia, Włochy, Australia, Kanada, Francja, Polska