Creatine for Acute Kidney Injury

Overseen By Assistant Professor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Northern Iowa

Must not be taking: NSAIDs

Disqualifiers: Cardiovascular, Metabolic, Renal, Neurologic, others

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 45 years old.

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

Physical Activity Level: Classified as 'active' engaging in planned exercise at least 3x/week, for a minimum of 30 minutes per session, over the past 3 months

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)

I take medications or supplements that affect my body's response to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete paperwork, cognitive assessments, and a maximal effort graded exercise test

1 day

1 visit (in-person)

Supplementation

Participants ingest 20 grams per day of creatine monohydrate or placebo for seven consecutive days

7 days

Exercise Trials

Participants undergo two exercise trials in a heated chamber, cycling for 90 minutes with cognitive and physiological assessments

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for changes in urinary biomarkers and cognitive performance post-exercise

1 hour post-exercise

What Are the Treatments Tested in This Trial?

Interventions

• Creatine Monohydrate
• Maltodextrin

How Is the Trial Designed?

Group I: Creatine Monohydrate Experimental Treatment 1 Intervention

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

Group II: Placebo (Maltodextrin) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Northern Iowa

Lead Sponsor

Trials

3

Recruited

2,400+