Recruiting

Creatine Monohydrate

Sponsor:

University of Northern Iowa

Code:

NCT07472426

Conditions

Acute Kidney Injury

Exertional Heat Illness

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Creatine Monohydrate

Maltodextrin (Placebo)

Study Details

Brief summary:

The goal of this clinical trial is to learn if one week of creatine monohydrate supplementation alters inflammation, markers of acute kidney injury (AKI) risk, and cognitive performance in active, young, healthy volunteers. The main questions it aims to answer are:

1. Does one-week of creatine supplementation alter urinary markers of inflammation (cytokines) during exercise in the heat when compared to placebo?
2. Does one-week of creatine supplementation alter markers of AKI during exercise in the heat when compared to placebo?
3. Does one-week of creatine supplementation attenuate reductions in cognitive measures as a response of fatigue from exertional heat stress.

Researchers will compare creatine monohydrate to a placebo (maltodextrin) to see if it alters inflammation, risk of acute kidney injury, and cognition after exercise in the heat.

Participants will :

  • Complete a baseline aerobic exercise test to measure VO2max
  • Ingest 20 grams per day of creatine monohydrate or placebo (maltodextrin) for seven consecutive days
  • Cycle for 90 minutes in a heated chamber (38 C, \~40% relative humidity), alternating low- and high-intensity exercise
  • Self-collect urine before, after, and one-hour after exercise
  • Self-insert a rectal thermistor to measure core temperature
  • Complete cognitive tasks using the NIH toolbox before and after exercise to assess cognition
  • Complete the other condition (placebo or creatine) at least 21 days later

Conditions

Acute Kidney Injury

Exertional Heat Illness

Study ID

NCT07472426

Start date

Mar 12, 2026

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range: 18-45 years old
  • Physical Activity Level: Classified as 'active' using the criteria of engaging in planned exercise at least 3x/week, for a minimum of 30 minutes per session, over the past 3 months
  • Aerobic Fitness Level: Subjects must have an aerobic fitness classification of at least 'good' per American College of Sports Medicine (ACSM) criteria and assessed via maximal oxygen uptake test
  • Health Status: Free of any known cardiovascular, metabolic, renal, or neurologic conditions.
  • Physical Limitations: Indicates no physical limitations to cycling for \~ 90 minutes
  • Supplementation: Reports no use of creatine within the past 4 weeks
  • Recent Illness: Reports no presence of illness, vomiting, or diarrhea in the previous three days.

Exclusion Criteria:

  • Known allergy to creatine or maltodextrin.
  • History of adverse heat-related events (e.g., heat exhaustion, heat stroke, severe dehydration requiring medical intervention)
  • Reports use of medications or supplements that may interfere with thermoregulation, heart rate, kidney injury or blood pressure responses during exercise (e.g. NSAID)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Creatine Monohydrate

Participants will ingest 20 grams per day of creatine monohydrate for 7 days, then 1 day of 5 grams before the exertional heat trial.

placebo comparator: Placebo (Maltodextrin)

Participants will ingest 20 grams per day of maltodextrin for 7 days, then 1 day of 5 grams before the exertional heat trial.

Interventions

Creatine Monohydrate

20 grams per day of creatine monohydrate for 7 days, followed by 1 day of 5 grams of supplementation.

Maltodextrin (Placebo)

Participants will ingest 20 grams per day for 7 days, followed by 1 day of 5 grams.

Primary outcome measure

  • Change in Urine Biomarker of Acute Kidney Injury Risk from Creatine Use Prior to Exercise in the Heat (The mathematical product of IGBFP7 and TIMP-2 [IGFBP7 x TIMP-2; NephroCheck®]) [ Time Frame: Change in urinary IGBP7 x TIMP-2 from immediately before exercise in the heat to 1 hour after exercise in the heat. ]

Central Contacts and Locations

Central contacts

Assistant Professor, PhD

5635137807jonathan.specht@uni.edu

Locations

Wellness and Recreation Center

Recruiting

Cedar Falls, Iowa, United States, 50614

Contacts

Jonathan Assistant Professor, PhD

563-513-7807jonathan.specht@uni.edu

More Information

Sponsor

University of Northern Iowa

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • acute kidney injury
  • creatine monohydrate
  • exertional heat stress
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Northern Iowa on 2026-03-16.