UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060528 |
|---|---|
| Receipt number | R000069241 |
| Scientific Title | The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction |
| Date of disclosure of the study information | 2026/02/02 |
| Last modified on | 2026/01/30 19:55:03 |
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Basic information
Public title
The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction
Acronym
The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction
Scientific Title
The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction
Scientific Title:Acronym
The effects of creatine supplementation on athletic and cognitive performance in collegiate student-athletes following a short-term sleep restriction
Region
| Japan |
Condition
Condition
Healthy adults / University-affiliated student-athletes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the effects of short-term sleep restriction on athletic and cognitive performance in collegiate student-athletes and to examine whether creatine can mitigate the potential effects of sleep restriction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise load test, Muscle strength evaluation.
Key secondary outcomes
Attention test, The simple reaction time test, Subjective fatigue assessment, Cognitive function assessment
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Creatine supplementation (0.35g/kg/day for 5 days)+ 6 hours of sleep restriction for 5 days
Interventions/Control_2
Placebo + 6 hours of sleep restriction for 5 days
Interventions/Control_3
Control group (8 hours of sleep for 5 days)
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Healthy male university student athletes
2)Individuals who are capable of making an independent decision regarding participation in the study
3)Non smokers
4)Individuals who have not used prescription sleep medications or over-the-counter sleep aids on a long-term basis (more than 1 year)
Key exclusion criteria
1)Individuals with allergies to standard foods or the test food
2)Individuals with suspected or diagnosed severe gastrointestinal, hepatic, renal, cardiovascular, hematological, or endocrine disorders, or malignant neoplasms; those with a history of such diseases; those currently receiving medical treatment; or those with ongoing medical conditions
3)Individuals with sleep disorders such as insomnia who have previously received treatment
4)Individuals who, during the habituation period (5 days), complied with controlled bedtime/wake-time schedules and wore an activity tracker to record sleep, and who experienced sleep duration of less than 6 hours on three or more days
5)Individuals who consumed excessive amounts of alcohol during the habituation period (5 days)*
6)Individuals who regularly use, or plan to use during the study period, supplements, medications, or health foods containing creatine (including Foods for Specified Health Uses, Foods with Function Claims, or Nutrient Function Foods)
7)Individuals who are unable to abstain from alcohol consumption during the experimental period (Days 0~5)
8)Individuals who participated in another study within one month prior to the start of this study, or who plan to participate in another similar study after providing consent for this study
*Definition of excessive alcohol consumption:
Alcohol intake of one 'go' of sake or more, three or more times per week, equivalent to:
/One medium bottle of beer
/One double shot of whisky
/0.6 'go' of shochu
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ruinian |
| Middle name | |
| Last name | Jin |
Organization
Sendai University
Division name
Graduate School of Sports Science
Zip code
989-1693
Address
2 Chome-2-18 Funaokaminami, Shibata, Shibata District, Miyagi 989-1693
TEL
0224-51-9856
r-jin@sendai-u.ac.jp
Public contact
Name of contact person
| 1st name | Ruinian |
| Middle name | |
| Last name | Jin |
Organization
Sendai University
Division name
Graduate School of Sports Science
Zip code
989-1693
Address
2 Chome-2-18 Funaokaminami, Shibata, Shibata District, Miyagi 989-1693
TEL
0224-51-9856
Homepage URL
r-jin@sendai-u.ac.jp
Sponsor or person
Institute
Sendai University
Institute
Department
Personal name
Funding Source
Organization
Sendai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai University, Research Ethics Review Committee
Address
2 Chome-2-18 Funaokaminami, Shibata, Shibata District, Miyagi 989-1693
Tel
0224-55-1121
r-jin@sendai-u.ac.jp
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 | 02 | Month | 02 | 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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 03 | 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 | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069241
