UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054436 |
|---|---|
| Receipt number | R000062171 |
| Scientific Title | Elucidation of the factors that determine inter-individual variability in exercise-induced inflammation and stress responses |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2025/05/20 14:54:19 |
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Basic information
Public title
Study on inter-individual variability in inflammation and stress response to exercise
Acronym
Study on inter-individual variability in inflammation and stress response to exercise
Scientific Title
Elucidation of the factors that determine inter-individual variability in exercise-induced inflammation and stress responses
Scientific Title:Acronym
Study on inter-individual variability in inflammation and stress response to exercise
Region
| Japan |
Condition
Condition
Exercise-induced inflammation and stress response
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify inter-individual variability in inflammatory and stress responses to exercise and their determinants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
White blood cell count/differentiation (total white blood cell count, neutrophils, monocytes, lymphocytes)
Inflammation/stress indicators (CRP, IL-6, IL-1-beta, TNF-alpha, etc.)
Stress hormones (cortisol, catecholamines, ACTH, etc.)
Leukocyte activating factors (myeloperoxidase, calprotectin, elastase, etc.)
Oxidative stress indicators (protein carbonyl, isoprostane, 8-OH-dG, glutathione/oxidized glutathione ratio, etc.)
Key secondary outcomes
Exosome contents (Comprehensive analysis of proteins, lipids, miRNA, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Drink water before, during, and after 30 minutes of cycling exercise at an intensity of 75% to 80% VO2max
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male aged 18-39
Key exclusion criteria
Those who have chronic diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6745
Homepage URL
tanisawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University, Ethics Review Committee on Research with Human Subjects
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2024 | Year | 05 | Month | 20 | 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
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062171
