CreatineNCT05109039
Creatine Supplementation in Female Collegiate Dancers
A study testing Creatine in people with Creatine, run by University of Idaho at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Creatine
- What is being tested?
- Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Collegiate dance major or minor
Who cannot join
- Injured within the past 6 months
- Currently consuming creatine supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Creatine
- Being tested
- Creatine, Placebo
- Keywords
- creatine, body composition, dancer, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Participants will consume 0.1g/kg body weight of creatine with 0.1g/kg body weight of maltodextrin for 42 consecutive days
PlaceboDietary supplement
Participants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Creatine Supplementation | Experimental | Not described Receives: Dietary Supplement: Creatine |
| Placebo Supplementation | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat mass from baseline after 42 days
Dual energy x-ray absorptiometry used to assess fat mass (% and kg)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Change from baseline cognitive performance at 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start27 Sep 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CreatineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Brown, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109039
- Sponsor's protocol ID
- 21-181
- Status last verified
- Aug 2022
- First submitted
- 26 Oct 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation on Performance, Body Composition and Mental Health in Female Collegiate Dancers
- ClinicalTrials.gov ID
- NCT05109039
- Acronym / sponsor ID
- 21-181
- Conditions
- Creatine
- Keywords
- creatine, body composition, dancer, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Supplementation | Experimental | Dietary Supplement: Creatine |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Collegiate dance major or minor
Key exclusion criteria (2 listed)
- Injured within the past 6 months
- Currently consuming creatine supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineParticipants will consume 0.1g/kg body weight of creatine with 0.1g/kg body weight of maltodextrin for 42 consecutive days | Dietary supplement | Creatine Supplementation |
| PlaceboParticipants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days | Dietary supplement | Placebo Supplementation |
Primary outcome
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 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 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 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 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 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 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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Creatine, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fat mass from baseline after 42 days (time frame: Change from baseline fat mass at 42 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.