UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060965 |
|---|---|
| Receipt number | R000069662 |
| Scientific Title | Comprehensive Analysis of Exercise-Induced Changes in the Gut Microbiota and Metabolism |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/17 17:37:23 |
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Basic information
Public title
A Study on Exercise-Induced Changes in the Gut Microbiota and Metabolism
Acronym
A Study on Exercise-Induced Changes in the Gut Microbiota and Metabolism
Scientific Title
Comprehensive Analysis of Exercise-Induced Changes in the Gut Microbiota and Metabolism
Scientific Title:Acronym
Comprehensive Analysis of Exercise-Induced Changes in the Gut Microbiota and Metabolism
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in gut microbiota and metabolism-related factors between periods with and without exercise.
Basic objectives2
Others
Basic objectives -Others
Exploratory analysis of changes in gut microbiota and metabolomic profiles associated with exercise.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in gut microbiota composition, and fecal and plasma metabolomic profiles between exercise and non-exercise periods.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During the exercise period (4 weeks), participants will be required to perform physical activity of 4 METs or more for 30 minutes or more per session, totaling 180 minutes or more per week, with no more than one consecutive day without exercise. In addition, structured exercise (non-lifestyle physical activity) must total 12 MET-hours or more per week, and these conditions will be maintained for at least 4 weeks.
During the non-exercise period (4 weeks), participants will refrain from regular structured exercise for at least 4 weeks, and structured exercise will be limited to 4 MET-hours or less per week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older who have no underlying medical conditions or regular medications, are able to perform exercise, and have provided written informed consent after receiving an explanation of the study.
Key exclusion criteria
1. Individuals with chronic medical conditions requiring pharmacological treatment.
2. Individuals who are unable to perform exercise.
3. Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Iwabu |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Deptarment of Endocrinology, Metabolism and Nephrology
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
m-iwabu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Hada |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Deptarment of Endocrinology, Metabolism and Nephrology
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
Homepage URL
mikiko-o@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Others
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
Central Ethics Committee of Nippon Medical School Foundation
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel
+81-3-3822-2131
chuorinri.group@nms.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 | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069662
