NCT07867041

Brief Summary

This study examined whether short-term creatine supplementation affects cognitive function in healthy young adults. Participants were randomly assigned to take either creatine monohydrate or a placebo for 10 days. Participants took 30 grams per day, divided into six 5-gram doses. Before and after the supplementation period, participants completed cognitive tests designed to assess areas such as memory, attention, reaction time, and processing speed. Participants also completed a 30-minute mentally challenging Stroop task, and brain oxygenation was measured during cognitive testing using functional near-infrared spectroscopy (fNIRS). The purpose of the study was to determine whether 10 days of high-dose creatine supplementation improves cognitive performance compared with placebo following a mentally challenging task.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

8 months

First QC Date

September 29, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Creatine MonohydrateCognitive FunctionMental FatigueStroop TaskFunctional Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (3)

  • Cognitive Performance Standard Scores Assessed by Central Nervous System Vital Signs (CNSVS)

    Cognitive performance was assessed using the Central Nervous System Vital Signs (CNSVS) computerized neurocognitive assessment battery. Standardized scores were obtained for cognitive domains including memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, simple attention, and motor speed. Standard scores are age-normalized with a mean of 100 and standard deviation of 15, with higher scores indicating better cognitive performance.

    Baseline and after 10 days of supplementation

  • Stroop Task Performance - Reaction Time

    Mean reaction time during the Stroop cognitive task, measured in milliseconds. Reaction times will be averaged across the specified task blocks at each assessment time point.

    Baseline and after 10 days of supplementation

  • Stroop Test Performance - Accuracy

    Accuracy during the Stroop cognitive task, expressed as the percentage of correctly completed trials at each assessment time point.

    Baseline and after 10 days of supplementation.

Secondary Outcomes (3)

  • Concentration of Prefrontal Cortex Oxygenation Assessed by Functional Near-Infrared Spectroscopy

    Baseline and after 10 days of supplementation

  • Subjective Mental Fatigue Assessed Using a Visual Analog Scale

    During cognitive testing at baseline and after 10 days of supplementation

  • Subjective Energy Assessed Using a Visual Analog Scale

    During cognitive testing at baseline and after 10 days of supplementation.

Study Arms (2)

Creatine Monohydrate

EXPERIMENTAL

Participants received 30 g/day of creatine monohydrate for 10 consecutive days, divided into six 5-g doses consumed throughout the day and mixed with food or water.

Dietary Supplement: Creatine Monohydrate

Placebo

PLACEBO COMPARATOR

Participants received 30 g/day of maltodextrin placebo for 10 consecutive days, divided into six 5-g doses consumed throughout the day and mixed with food or water.

Dietary Supplement: Maltodextrin Placebo

Interventions

Creatine MonohydrateDIETARY_SUPPLEMENT

Participants consumed 30 g/day of creatine monohydrate (Creapure®; AlzChem Trostberg GmbH, Germany) for 10 consecutive days. The daily dose was divided into six 5-g doses consumed throughout the day and mixed with food or water. Each 5-g dose was provided in an individual bag.

Creatine Monohydrate
Maltodextrin PlaceboDIETARY_SUPPLEMENT

Participants consumed 30 g/day of maltodextrin (Dry Maltodextrin; Cargill, Minnesota, USA) for 10 consecutive days. The daily dose was divided into six 5-g doses consumed throughout the day and mixed with food or water. The placebo was provided in individual bags and was similar to the creatine intervention in taste, color, texture, and appearance.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Healthy adult.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • History of cognitive impairment.
  • Previous diagnosis of a neurological or neurophysiological condition, including dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, Charcot-Marie-Tooth disease, amyotrophic lateral sclerosis, or muscular dystrophy.
  • History of traumatic brain injury, including concussion.
  • Pre-existing kidney or liver abnormalities.
  • Consumption of dietary products containing creatine within 30 days prior to the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Northern Iowa

Cedar Falls, Iowa, 50614, United States

Location

MeSH Terms

Conditions

Mental Fatigue

Interventions

Creatine

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 9, 2026

Study Start

April 10, 2024

Primary Completion

December 3, 2024

Study Completion

December 3, 2024

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations