Creatine and Motor Skill Acquisition

NCT ID: NCT05201651

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-08-31

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.

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.

Conditions

Young Healthy Adults (no Medical Condition/Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Creatine

Participants will orally consume creatine (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days.

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_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.

Placebo

Participants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days.

Group Type: PLACEBO_COMPARATOR

Maltodextrin Placebo

Intervention Type: DIETARY_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.

Interventions

Creatine Monohydrate

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.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin Placebo

Participants will orally consume maltodextrin placebo (20 grams in 4×5-gram servings for seven days), followed by 3-g/day during training days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• omnivore diet

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cameron S Mang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

University of Regina

Regina, Saskatchewan, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Cameron S Mang, PhD

Role: CONTACT

cameron.mang@uregina.ca

3065854066

Darren G Candow, PhD

Role: CONTACT

darren.candow@uregina.ca

306-585-4906

Facility Contacts

Cameron S Mang, PhD

Role: primary

cameron.mang@uregina.ca

3065854066

Darren G Candow, PhD

Role: backup

darren.candow@uregina.ca

3065854906

Other Identifiers

2021-139

Identifier Type: -

Identifier Source: org_study_id