UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058720 |
|---|---|
| Receipt number | R000067145 |
| Scientific Title | A cross-sectional study of gut microbiota |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 11:16:46 |
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Basic information
Public title
A cross-sectional study of gut microbiota
Acronym
A cross-sectional study of gut microbiota
Scientific Title
A cross-sectional study of gut microbiota
Scientific Title:Acronym
A cross-sectional study of gut microbiota
Region
| Japan |
Condition
Condition
Healthy Volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the relationship between gut microbiota and muscle parameters in healthy volunteers.
Basic objectives2
Others
Basic objectives -Others
To explore the relationship between gut microbiota and muscle parameters in healthy volunteers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of muscle parameters, gut microbiota, and background information of the subject
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are voluntarily giving written informed consent.
2) Healthy volunteers aged between 50 and 79.
3) Subjects whose BMI is below 30.
Key exclusion criteria
(1) Subjects who cause allergic symptoms in foods and medicines.
(2) Subjects who contract or are under treatment for diseases.
(3) Subjects with systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more at screening test.
(4) Alcoholic drinkers (more than 40 grams of pure alcohol per day).
(5) Subjects whose dietary patterns are highly irregular and may interfere with the study outcomes.
(6) Subjects who can't stop using, medicin, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods.
(7) Subjects with exercise habits that may influence the outcomes of the study.
(8) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Takahashi |
Organization
Otsuka Holdings Co., Ltd.
Division name
Nutraceutical Business, Global Strategy and Planning Headquarters
Zip code
108-8241
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1410
takahashi.minoru@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Noguchi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Nutraceuticals Research Institute (Otsu research site)
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu-shi, Shiga
TEL
077-519-0111
Homepage URL
Noguchi.Hiroki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakucho Build. 2F, 2-1-2 Shinjuku, Shinjuku-ku, Tokyo
Tel
03-4405-1899
ethics_board@drc-web.co.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 | 08 | Month | 07 | 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 | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To explore the relationship between gut microbiota and muscle parameters in healthy volunteers.
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067145
