NCT05201651

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

November 10, 2021

Last Update Submit

February 22, 2022

Conditions

Keywords

motor learningtranscranial magnetic stimulationmotor cortexcorticospinal excitabilitycreatine

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days

Secondary Outcomes (3)

  • Single pulse motor evoked potential amplitude

    Days 1 and 3 of training

  • Short-interval intracortical inhibition motor evoked potential amplitude

    Days 1 and 3 of training

  • Intracortical facilitation motor evoked potential amplitude

    Days 1 and 3 of training

Study Arms (2)

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.

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.

Dietary Supplement: Maltodextrin Placebo

Interventions

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.

Creatine
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.

Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • omnivore diet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S5N6, Canada

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Creatine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Cameron S Mang, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron S Mang, PhD

CONTACT

Darren G Candow, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind. Individual without other involvement in study has study codes and prepares and distributes study kits containing creatine and placebo (similar appearance).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants assigned to receive creatine supplementation or placebo.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

January 21, 2022

Study Start

February 10, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Will not share individual participant data.

Locations