Young Healthy Adults (no Medical Condition/Disease)Early Phase 1NCT05201651
Creatine and Motor Skill Acquisition
A Early Phase 1 study testing Creatine Monohydrate in people with Young Healthy Adults (no Medical Condition/Disease), run by University of Regina at 1 site in Canada.
Trial summary
The investigators will conduct a double-blind, placebo-controlled, repeated measures study of the effects of oral creatine monohydrate supplementation on motor skill acquisition and neurophysiology in young healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Healthy Adults (no Medical Condition/Disease)
- What is being tested?
- Creatine Monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2022to 31 Aug 2022
- Phase
- Early Phase 1
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- omnivore diet
Who cannot join
- pre-existing liver abnormalities
- pre-existing kidney abnormalities
- pre-existing neuromuscular abnormalities
- contraindications to transcranial magnetic stimulation
- consumption of dietary supplements containing creatine within 30 days prior to the start of the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S5N6
Cameron S Mang, PhD, 3065854066, cameron.mang@uregina.ca
Darren G Candow, PhD, 3065854906, darren.candow@uregina.ca
About this study
Official title: Effects of Creatine Supplementation on Motor Skill Acquisition and Related Neurophysiology
The investigators will conduct a double-blind, placebo-controlled, repeated measures study of the effects of oral creatine monohydrate supplementation on motor skill acquisition and neurophysiology in young healthy adults. After baseline testing, participants will be randomized to receive creatine supplementation or placebo for seven days. Participants will then complete three days of training on a motor skill task while consuming a maintenance dosage of creatine or placebo. TMS measures of neurophysiology will be assessed at baseline, and pre- and post-skill training on the first and third training days.
Read the detailed description
Participants: Thirty-six young healthy adults between 18-39 years of age will participate in the study. Participants will follow an omnivore diet given differences in response to creatine supplementation among vegetarians.
Group allocation: Participants will be allocated to study groups (i.e., creatine, placebo) using blocked randomization that stratifies by sex (male, female).
Supplementation and diet: An individual blind to supplement and group allocation will prepare participant study kits. Each study kit will contain daily supplementation bags for the duration of the study, detailed instructions, and a compliance log. Creatine (Creapure® AlzChem Trostberg GmbH, Germany) and placebo (Globe Plus 10 DE Maltodextrin, Univar Canada) will be in powder form and be very similar in color, texture, and appearance. After baseline testing, participants will orally consume creatine or placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. This 3-g/day dosage has been shown to maintain cellular creatine levels. Adherence with the supplementation protocol will be assessed by the compliance log. Possible adverse events to supplementation (i.e., minor gastrointestinal irritation) will be assessed using adverse event forms. Upon completion of the study, participants will be asked to guess whether creatine or placebo had been administered. Habitual dietary intake will be determined by 3-day food logs completed by participants prior to the study.
Motor skill task: Participants will perform an "intercept and release" task which uses a Microsoft Kinect sensor and open-source software to track 3-dimensional joint movement. Participants will be instructed to "save the world" through control of an on-screen cursor (i.e., spaceship) using movement of their dominant arm to intercept a moving object (an asteroid) as it emerges from the side of a computer screen. After interception of the object, participants will be required to accurately throw the object to hit a target (the sun). The task will progress through 10 stages of increasing difficulty (i.e., increasing object speed, decreasing target size) as skill performance improves. The stages of difficulty are designed to challenge participants, maintain engagement, and prevent plateaus in performance.
Participants will complete one block of 200 movements (i.e., 100 object interceptions, 100 object throws) at the easiest level of difficulty in the baseline testing session. After the initial 7-day creatine supplementation period, three training sessions will be completed on consecutive days. A training session will involve five blocks of 200 movements, for 1,000 skilled arm movements per session (~45 minutes), and a total of 3,000 training movements over the course of the study. A plot of object interception time (y-axis) by successful movement trial (x-axis) across the training period (i.e., days 1-3) will be generated for each participant and fit with an exponential curve. The curve fitting parameter that represents rate of skill acquisition will be extracted for each participant as the primary dependent variable.
Transcranial magnetic stimulation (TMS): Using neuronavigation software, TMS will be applied over the primary motor cortex to elicit motor evoked potentials (MEPs) in the extensor carpii radialis muscle of the dominant arm, a muscle involved in performance of the motor skill task. Using standard procedures, the investigators will collect a battery of TMS measures that provide indices of corticospinal excitability and gamma-aminobutyric acid and glutamate signaling at baseline, and pre- and post-skill training on the first and third days.
- Being tested
- Creatine Monohydrate, Maltodextrin Placebo
- Keywords
- motor learning, transcranial magnetic stimulation, motor cortex, corticospinal excitability, creatine
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Participants will orally consume creatine (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. This 3-g/day dosage has been shown to maintain cellular creatine levels.
Maltodextrin PlaceboDietary supplement
Participants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days.
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Participants will orally consume creatine (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. Receives: Dietary Supplement: Creatine Monohydrate |
| Placebo | Placebo comparator | Participants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. Receives: Dietary Supplement: Maltodextrin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in movement time
Both groups will perform a skill acquisition task that involves moving the dominant upper limb to direct a cursor towards moving targets presented on a computer screen. The task will be practiced over a period of three days. The time required to reach each moving target will be measured (i.e., movement time) with faster times indicating improved performance. The rate of improvement on the task over the three days will be determined.
Measured: 3 days
Secondary outcomes (3)
Single pulse motor evoked potential amplitude
Amplitude of motor evoked potentials measured with electromyography and elicited by single-pulse transcranial magnetic stimulation. Provides a marker of corticospinal excitability.
Measured: Days 1 and 3 of training
Short-interval intracortical inhibition motor evoked potential amplitude
Amplitude of motor evoked potentials measured with electromyography and elicited by transcranial magnetic stimulation using paired-pulse short interval intracortical inhibition paradigm.
Measured: Days 1 and 3 of training
Intracortical facilitation motor evoked potential amplitude
Amplitude of motor evoked potentials measured with electromyography and elicited by transcranial magnetic stimulation using paired-pulse intracortical facilitation paradigm.
Measured: Days 1 and 3 of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start10 Feb 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Healthy Adults (no Medical Condition/Disease)Studies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned to receive creatine supplementation or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron S Mang, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201651
- Sponsor's protocol ID
- 2021-139
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation on Motor Skill Acquisition and Related Neurophysiology
- ClinicalTrials.gov ID
- NCT05201651
- Acronym / sponsor ID
- 2021-139
- Keywords
- motor learning, transcranial magnetic stimulation, motor cortex, corticospinal excitability, creatine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 21 Jan 2022 (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.
The investigators will conduct a double-blind, placebo-controlled, repeated measures study of the effects of oral creatine monohydrate supplementation on motor skill acquisition and neurophysiology in young healthy adults. After baseline testing, participants will be randomized to receive creatine supplementation or placebo for seven days. Participants will then complete three days of training on a motor skill task while consuming a maintenance dosage of creatine or placebo. TMS measures of neurophysiology will be assessed at baseline, and pre- and post-skill training on the first and third training days.
Detailed description
Participants: Thirty-six young healthy adults between 18-39 years of age will participate in the study. Participants will follow an omnivore diet given differences in response to creatine supplementation among vegetarians.
Group allocation: Participants will be allocated to study groups (i.e., creatine, placebo) using blocked randomization that stratifies by sex (male, female).
Supplementation and diet: An individual blind to supplement and group allocation will prepare participant study kits. Each study kit will contain daily supplementation bags for the duration of the study, detailed instructions, and a compliance log. Creatine (Creapure® AlzChem Trostberg GmbH, Germany) and placebo (Globe Plus 10 DE Maltodextrin, Univar Canada) will be in powder form and be very similar in color, texture, and appearance. After baseline testing, participants will orally consume creatine or placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. This 3-g/day dosage has been shown to maintain cellular creatine levels. Adherence with the supplementation protocol will be assessed by the compliance log. Possible adverse events to supplementation (i.e., minor gastrointestinal irritation) will be assessed using adverse event forms. Upon completion of the study, participants will be asked to guess whether creatine or placebo had been administered. Habitual dietary intake will be determined by 3-day food logs completed by participants prior to the study.
Motor skill task: Participants will perform an "intercept and release" task which uses a Microsoft Kinect sensor and open-source software to track 3-dimensional joint movement. Participants will be instructed to "save the world" through control of an on-screen cursor (i.e., spaceship) using movement of their dominant arm to intercept a moving object (an asteroid) as it emerges from the side of a computer screen. After interception of the object, participants will be required to accurately throw the object to hit a target (the sun). The task will progress through 10 stages of increasing difficulty (i.e., increasing object speed, decreasing target size) as skill performance improves. The stages of difficulty are designed to challenge participants, maintain engagement, and prevent plateaus in performance.
Participants will complete one block of 200 movements (i.e., 100 object interceptions, 100 object throws) at the easiest level of difficulty in the baseline testing session. After the initial 7-day creatine supplementation period, three training sessions will be completed on consecutive days. A training session will involve five blocks of 200 movements, for 1,000 skilled arm movements per session (~45 minutes), and a total of 3,000 training movements over the course of the study. A plot of object interception time (y-axis) by successful movement trial (x-axis) across the training period (i.e., days 1-3) will be generated for each participant and fit with an exponential curve. The curve fitting parameter that represents rate of skill acquisition will be extracted for each participant as the primary dependent variable.
Transcranial magnetic stimulation (TMS): Using neuronavigation software, TMS will be applied over the primary motor cortex to elicit motor evoked potentials (MEPs) in the extensor carpii radialis muscle of the dominant arm, a muscle involved in performance of the motor skill task. Using standard procedures, the investigators will collect a battery of TMS measures that provide indices of corticospinal excitability and gamma-aminobutyric acid and glutamate signaling at baseline, and pre- and post-skill training on the first and third days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants assigned to receive creatine supplementation or placebo.
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: Creatine MonohydrateParticipants will orally consume creatine (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin PlaceboParticipants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- omnivore diet
Key exclusion criteria (5 listed)
- pre-existing liver abnormalities
- pre-existing kidney abnormalities
- pre-existing neuromuscular abnormalities
- contraindications to transcranial magnetic stimulation
- consumption of dietary supplements 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 will orally consume creatine (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. This 3-g/day dosage has been shown to maintain cellular creatine levels. | Dietary supplement | Creatine |
| Maltodextrin PlaceboParticipants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days. | Dietary supplement | Placebo |
Primary outcome
Rate of change in movement time
Time frame: 3 days
Both groups will perform a skill acquisition task that involves moving the dominant upper limb to direct a cursor towards moving targets presented on a computer screen. The task will be practiced over a period of three days. The time required to reach each moving target will be measured (i.e., movement time) with faster times indicating improved performance. The rate of improvement on the task over the three days will be determined.
3 secondary outcomes
Single pulse motor evoked potential amplitude
Time frame: Days 1 and 3 of training
Short-interval intracortical inhibition motor evoked potential amplitude
Time frame: Days 1 and 3 of training
Intracortical facilitation motor evoked potential amplitude
Time frame: Days 1 and 3 of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No. Will not share individual participant data.
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.
Cameron S Mang, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Creatine Monohydrate in people with Young Healthy Adults (no Medical Condition/Disease), run by University of Regina at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2022. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cameron S Mang, PhD (3065854066, cameron.mang@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in movement time (time frame: 3 days). 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 24 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.