Creatine Supplementation in Female Collegiate Dancers

August 11, 2022 updated by: Ann Brown, University of Idaho

Effects of Creatine Supplementation on Performance, Body Composition and Mental Health in Female Collegiate Dancers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Moscow, Idaho, United States, 83844
        • University of Idaho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Collegiate dance major or minor

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Creatine Supplementation
Dietary supplement: Creatine
Participants will consume 0.1g/kg body weight of creatine with 0.1g/kg body weight of maltodextrin for 42 consecutive days
Placebo Comparator: Placebo Supplementation
Dietary supplement: Placebo
Participants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fat mass from baseline after 42 days
Time Frame: Change from baseline fat mass at 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
Time Frame: Change from baseline lean mass at 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
Time Frame: Change from baseline visceral adipose tissue at 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
Time Frame: Change from baseline peak muscular strength at 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
Time Frame: Change from baseline peak vertical jump height at 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
Time Frame: Change from baseline upper body muscular power at 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
Time Frame: Change from baseline muscular lower at 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
Time Frame: Change from baseline depression, anxiety and stress at 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
Time Frame: Change from baseline cognitive performance at 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Idaho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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