- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109039
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Creatine Supplementation
|
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
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Participants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days
|
What is the study measuring?
Primary Outcome Measures
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
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)
September 27, 2021
Primary Completion (Actual)
January 30, 2022
Study Completion (Actual)
January 30, 2022
Study Registration Dates
First Submitted
October 26, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
August 15, 2022
Last Update Submitted That Met QC Criteria
August 11, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID 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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