UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059369 |
|---|---|
| Receipt number | R000067902 |
| Scientific Title | Effects of Creatine Supplementation on Endurance Exercise Performance with Varying Exercise Intensity |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/10 15:50:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Creatine Supplementation on Endurance Exercise Performance with Varying Exercise Intensity
Acronym
Effects of Creatine Supplementation on Endurance Exercise Performance with Varying Exercise Intensity
Scientific Title
Effects of Creatine Supplementation on Endurance Exercise Performance with Varying Exercise Intensity
Scientific Title:Acronym
Effects of Creatine Supplementation on Endurance Exercise Performance with Varying Exercise Intensity
Region
| Japan |
Condition
Condition
Healthy adults / University-affiliated cross-country ski athletes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of creatine supplementation on endurance exercise performance with varying exercise intensities in university cross-country ski athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise duration until exhaustion
Key secondary outcomes
Rating of Perceived Exertion, Respiratory Exchange Ratio, Oxygen Uptake, Ventilatory Threshold, Anaerobic Threshold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Creatine supplementation (20 g per day for 6 days)
Interventions/Control_2
Continue normal daily activities
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Cross-country skiing athletes belonging to the university
2.Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
1.Individuals with musculoskeletal disorders that may interfere with exercise performance
2.Individuals with respiratory, cardiovascular, metabolic, or other conditions that may pose a health risk during exercise
3.Individuals with infections, such as fever or acute infectious diseases
4.Individuals currently taking medications that may affect the study outcomes
5.Individuals who plan to consume caffeine during the study period
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8586
yosuke.yamada.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hyeon-Ki |
| Middle name | |
| Last name | Kim |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8586
Homepage URL
hyeon-ki.kim.c8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2025 | Year | 10 | Month | 10 | 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
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067902
