NCT05109039

Brief Summary

This study will be a 6 week creatine supplementation intervention with performance familiarization and pre and post testing. Participants will report to the human performance laboratory (HPL) for baseline to read and sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then complete a physical activity readiness questionnaire (PAR-Q) prior to performing any physical tasks. Participants will also be asked to complete testing below in the order described. Participants will become familiar with the pre/post performance tests, which include isokinetic testing, medicine ball throw, vertical jump, and Wingate testing. Twenty-four hours following visit 1, participants will return to the HPL for visit 2 where they will undergo a second familiarization session for the isokinetic testing and Wingate testing only - these two tests require individuals to provide maximal physical efforts and research suggests that participants should perform multiple familiarization trials before beginning experimental trials. At least 72 hours following visit 2, participants will return to the HPL for visit 3 to perform the baseline performance assessments. Following the baseline assessments, participants will be divided into two supplementation groups: creatine and placebo (maltodextrin). These groups will be randomized and matched based on body mass, hours of dance training per week, meat intake, and menstrual cycle phase. Participants will be asked to consume one of the two supplements daily for 42 consecutive days and maintain their regular dance training and eating behaviors. Participants will report to the HPL daily to receive their supplement between the hours of 12pm and 2pm. Following the last day of supplement consumption, participants will report to the HPL to perform post-testing assessments which will be identical to pre testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

October 26, 2021

Last Update Submit

August 11, 2022

Conditions

Keywords

creatine, body composition, dancer, cognition

Outcome Measures

Primary Outcomes (9)

  • Change in fat mass from baseline after 42 days

    Dual energy x-ray absorptiometry used to assess fat mass (% and kg)

    Change from baseline fat mass at 42 days

  • Change in lean mass from baseline after 42 days

    Dual energy x-ray absorptiometry used to assess lean mass (% and kg)

    Change from baseline lean mass at 42 days

  • Change in visceral adipose tissue from baseline after 42 days

    Dual energy x-ray absorptiometry used to assess visceral adipose tissue (cm2)

    Change from baseline visceral adipose tissue at 42 days

  • Change in peak muscular strength from baseline after 42 days

    Cybex isokinetic dynamometry used to assess peak muscular strength (W)

    Change from baseline peak muscular strength at 42 days

  • Change in peak vertical jump height from baseline after 42 days

    Cybex isokinetic dynamometry used to assess vertical jump height (in)

    Change from baseline peak vertical jump height at 42 days

  • Change in upper body muscular power from baseline after 42 days

    Seated medicine ball toss used to assess upper body muscular power (in)

    Change from baseline upper body muscular power at 42 days

  • Change in muscular power from baseline after 42 days

    Wingate anaerobic power test used to assess muscular power (W)

    Change from baseline muscular lower at 42 days

  • Change in depression, anxiety and stress score from baseline after 42 days

    Depression, anxiety and stress scale (from 0, normal to 42, extremely severe) used to assess depression, anxiety and stress

    Change from baseline depression, anxiety and stress at 42 days

  • Change in cognitive performance from baseline after 42 days

    NIH Toolbox for the assessment of Neurological and Behavioral Function ipad application to assess fluid cognitive measures including executive function, attention, episodic memory, processing speed, and working memory.

    Change from baseline cognitive performance at 42 days

Study Arms (2)

Creatine Supplementation

EXPERIMENTAL
Dietary Supplement: Creatine

Placebo Supplementation

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CreatineDIETARY_SUPPLEMENT

Participants will consume 0.1g/kg body weight of creatine with 0.1g/kg body weight of maltodextrin for 42 consecutive days

Creatine Supplementation
PlaceboDIETARY_SUPPLEMENT

Participants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days

Placebo Supplementation

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Collegiate dance major or minor

You may not qualify if:

  • Injured within the past 6 months
  • Currently consuming creatine supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

Location

MeSH Terms

Interventions

Creatine

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

September 27, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations