Effects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury Afte… (NCT07472426) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury After Exercise in the Heat
United States20 participantsStarted 2026-03-12
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at whether creatine supplements affect kidney injury risk markers after exercising in the heat — given that creatine can sometimes raise baseline kidney-related lab values, is my current kidney health and hydration status something that would make this worth discussing before I consider anything like this?
2The trial is measuring a specific kidney stress test called NephroCheck, which combines two proteins to flag early kidney injury risk — can you help me understand what my personal baseline risk for exercise-related acute kidney injury might be, and whether that changes how you'd view my participation in a study like this?
3Since this study involves exercising in the heat as part of the protocol, what physical conditions or medications I'm currently on might affect how safely I could handle that kind of environmental stress?
4This trial is in a 'not applicable' phase, which often means it's studying a supplement or behavior rather than a drug — does that change the level of safety unknowns I should be aware of compared to a standard pharmaceutical trial?
5If the results of this study eventually show that creatine does raise acute kidney injury markers after heat exercise, are there standard guidelines or alternatives already available that might address my concerns about kidney health during physical activity in hot conditions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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®])
Timeframe: Change in urinary IGBP7 x TIMP-2 from immediately before exercise in the heat to 1 hour after exercise in the heat.