UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059179 |
|---|---|
| Receipt number | R000067686 |
| Scientific Title | Exploring the Physiological Mechanisms Linking Fluid Regulation and Gut Function during Exercise in Hot Conditions |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/24 20:24:04 |
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Basic information
Public title
Exploring the Physiological Mechanisms Linking Fluid Regulation and Gut Function during Exercise in Hot Conditions
Acronym
Exploring the Physiological Mechanisms Linking Fluid Regulation and Gut Function during Exercise in Hot Conditions
Scientific Title
Exploring the Physiological Mechanisms Linking Fluid Regulation and Gut Function during Exercise in Hot Conditions
Scientific Title:Acronym
Exploring the Physiological Mechanisms Linking Fluid Regulation and Gut Function during Exercise in Hot Conditions
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on the possibility that exercise-induced sweating in hot environments may be associated with central fatigue and impaired renal function, leading to alterations in the gut environment. The aim is to investigate condition changes through the "kidney-gut axis" centered on fluid metabolism, thereby contributing to practical conditioning strategies in athletic settings.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in sweat composition and urinary biomarkers in response to heat, and their association with alterations in gut microbiota.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
60 minutes of moderate intensity running at 60 70% of HRmax
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Adult male athletes aged 18 to 35 who specialize in long-distance and marathon running and engage in routine training.
Key exclusion criteria
Healthy male participants without any history of injury or cardiovascular disease, and not on any regular medication.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Matsuo |
Organization
Shunan University
Division name
Department of Health and Sport Sciences, Faculty of Human Health Sciences
Zip code
745-8566
Address
843-4-2, Gakuendai, Shunan City, Yamaguchi, Japan
TEL
+81-834-34-3465
matsuo_k25@shunan-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Matsuo |
Organization
Shunan University
Division name
Department of Health and Sport Sciences, Faculty of Human Health Sciences
Zip code
745-8566
Address
843-4-2, Gakuendai, Shunan City, Yamaguchi, Japan
TEL
+81-834-34-3465
Homepage URL
matsuo_k25@shunan-u.ac.jp
Sponsor or person
Institute
Shunan University
Institute
Department
Personal name
Funding Source
Organization
Shunan University
Department of Health and Sport Sciences,
Faculty of Human Health Sciences
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
Shunan University
Address
843-4-2, Gakuendai, Shunan City, Yamaguchi, 745-8566, Japan
Tel
+81-834-28-8790
matsuo_k25@shunan-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
| 2025 | Year | 09 | Month | 24 | 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
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 20 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067686
