UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061541 |
|---|---|
| Receipt number | R000070406 |
| Scientific Title | Creatine loading enhances brain network connectivity and running performance in mentally fatigued soccer players-a randomized trial |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/12 19:04:30 |
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Basic information
Public title
Creatine loading enhances brain network connectivity and running performance in mentally fatigued soccer players-a randomized trial
Acronym
Creatine loading enhances brain network connectivity and running performance in mentally fatigued soccer players-a randomized trial
Scientific Title
Creatine loading enhances brain network connectivity and running performance in mentally fatigued soccer players-a randomized trial
Scientific Title:Acronym
Creatine loading enhances brain network connectivity and running performance in mentally fatigued soccer players-a randomized trial
Region
| Asia(except Japan) |
Condition
Condition
Pre-post test
Classification by specialty
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of days of creatine monohydrate loading on resting state functional connectivity of four major brain networks,default mode network, dorsal attention network, central executive network, and salience network,measured by fMRI in semiprofessional soccer players after induction of mental fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
YoYo Intermittent Recovery Test level distance,Resting state functional connectivity of brain networks,Peak heart rate during the YoYo IR1 test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
CreapureCrone300
Interventions/Control_2
pabelco
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
No injury, No neurological diseases or mental disorders, No metal objects in the body, Adherence to the protocol recommendations, Healthy habits (no smoking), No use of medication or supplement that could be considered an intervention,Having a history of participating in provincial competitions (at least two years prior)
Key exclusion criteria
Failure to participate in any of the tests, Unwillingness to continue participation in the study,Feeling pain or discomfort during testing throughout the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mohammad |
| Middle name | |
| Last name | Saleh |
Organization
USB
Division name
USB
Zip code
1491115719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
amirehsanbakhshandeh@gmail.com
Public contact
Name of contact person
| 1st name | Mohammad |
| Middle name | |
| Last name | Saleh |
Organization
shahid behshti
Division name
SBU
Zip code
1491115719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
amirehsanbakhshandeh@gmail.com
Sponsor or person
Institute
SELF
Institute
Department
Personal name
Funding Source
Organization
SELF
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahid Behshti
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
amirehsanbakhshandeh@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070406
