UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051749 |
|---|---|
| Receipt number | R000059062 |
| Scientific Title | Search for salivary and urinary markers to assess exercise stresses in athletes |
| Date of disclosure of the study information | 2023/07/29 |
| Last modified on | 2023/07/29 14:45:17 |
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Basic information
Public title
Search for salivary and urinary markers to assess exercise stresses in athletes
Acronym
Search for salivary and urinary markers to assess exercise stresses in athletes
Scientific Title
Search for salivary and urinary markers to assess exercise stresses in athletes
Scientific Title:Acronym
Search for salivary and urinary markers to assess exercise stresses in athletes
Region
| Japan |
Condition
Condition
healthy athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether measurement of markers such as cortisol in saliva and urine is useful for stress assessment in athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elevation of salivary cortisol concentrations
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy track and field athletes, wrestlers, basketball players, and soccer players who belong to companies or colleges. And healthy controls of the same age who do not belong to sports clubs.
Key exclusion criteria
Subjects who have experienced unfavorable symptoms, etc. and have been judged by the researcher in charge to discontinue the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Tsunekawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Clinical Laboratory Medicine
Zip code
371-8511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8576
ktsune@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Tsunekawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Clinical Laboratory Medicine
Zip code
371-8511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8576
Homepage URL
ktsune@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Ethics Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa-machi, Maebashi, Gunma
Tel
027-220-8740
ciru_hitotaisho-irb@ml.gunma-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
| 2023 | Year | 07 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the results of urine and saliva measurements with the results of exercise intensity, etc., and calculate Pearson's product-moment correlation coefficient, etc. A t-test is used to compare the mean values of each data between the two groups of athletes and volunteers, and analysis of covariance is performed to adjust for covariates.
Management information
Registered date
| 2023 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059062
