Cognitive Function AssessmentNCT07867041
Effects of Short-Term Creatine Supplementation on Cognitive Function in Healthy Young Adults
A study testing Creatine Monohydrate in people with Cognitive Function Assessment and Mental Fatigue, run by University of Northern Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function Assessment, Mental Fatigue
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Healthy adult.
- Willing and able to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Northern Iowa
Cedar Falls, Iowa, 50614
About this study
Official title: The Effects of Short-Term, High-Dosage Creatine Supplementation on Cognitive Measures Following Mental Fatigue in Healthy Young Adults
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.
- Conditions
- Cognitive Function Assessment, Mental Fatigue
- Being tested
- Creatine Monohydrate, Maltodextrin Placebo
- Keywords
- Creatine Monohydrate, Cognitive Function, Mental Fatigue, Stroop Task, Functional Near-Infrared Spectroscopy
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Maltodextrin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 10 days of supplementation.
Secondary outcomes (3)
Concentration of Prefrontal Cortex Oxygenation Assessed by Functional Near-Infrared Spectroscopy
Concentration of prefrontal cortex oxygenation was assessed using functional near-infrared spectroscopy (fNIRS; OctaMon+). Cerebral hemodynamic responses during cognitive testing were quantified using changes in oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (THb), and hemoglobin difference (HbDiff).
Measured: Baseline and after 10 days of supplementation
Subjective Mental Fatigue Assessed Using a Visual Analog Scale
Subjective mental fatigue was assessed using a visual analog scale (VAS) during each cognitive testing session. Ratings were obtained at five time points: before cognitive testing, midway through the 30-minute Stroop task, immediately following the Stroop task, midway through the CNS Vital Signs assessment, and following completion of the CNS Vital Signs assessment.
Measured: During cognitive testing at baseline and after 10 days of supplementation
Subjective Energy Assessed Using a Visual Analog Scale
Subjective energy was assessed using a visual analog scale (VAS) during each cognitive testing session. Ratings were obtained at five time points: before cognitive testing, midway through the 30-minute Stroop task, immediately following the Stroop task, midway through the CNS Vital Signs assessment, and following completion of the CNS Vital Signs assessment.
Measured: During cognitive testing at baseline and after 10 days of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 Apr 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867041
- Sponsor's protocol ID
- IRB-FY24-213
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-Term, High-Dosage Creatine Supplementation on Cognitive Measures Following Mental Fatigue in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07867041
- Acronym / sponsor ID
- IRB-FY24-213
- Conditions
- Cognitive Function Assessment, Mental Fatigue
- Keywords
- Creatine Monohydrate, Cognitive Function, Mental Fatigue, Stroop Task, Functional Near-Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Northern IowaUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate | Experimental | Dietary Supplement: Creatine MonohydrateParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Healthy adult.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateParticipants 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. | Dietary supplement | Creatine Monohydrate |
| Maltodextrin PlaceboParticipants 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. | Dietary supplement | Placebo |
Primary outcome
Cognitive Performance Standard Scores Assessed by Central Nervous System Vital Signs (CNSVS)
Time frame: Baseline and after 10 days of supplementation
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.
Stroop Task Performance - Reaction Time
Time frame: Baseline and after 10 days of supplementation
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.
Stroop Test Performance - Accuracy
Time frame: Baseline and after 10 days of supplementation.
Accuracy during the Stroop cognitive task, expressed as the percentage of correctly completed trials at each assessment time point.
3 secondary outcomes
Concentration of Prefrontal Cortex Oxygenation Assessed by Functional Near-Infrared Spectroscopy
Time frame: Baseline and after 10 days of supplementation
Subjective Mental Fatigue Assessed Using a Visual Analog Scale
Time frame: During cognitive testing at baseline and after 10 days of supplementation
Subjective Energy Assessed Using a Visual Analog Scale
Time frame: During cognitive testing at baseline and after 10 days of supplementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Cognitive Function Assessment and Mental Fatigue, run by University of Northern Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance Standard Scores Assessed by Central Nervous System Vital Signs (CNSVS) (time frame: Baseline and after 10 days of supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.