UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063147 |
|---|---|
| Receipt number | R000072277 |
| Scientific Title | Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/02 12:53:16 |
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Basic information
Public title
Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X
Acronym
Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X
Scientific Title
Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X
Scientific Title:Acronym
Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between long-term consumption of Food X and biological age and gut environment.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between long-term consumption of Food X and biological age and gut environment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biological age and gut microbiota composition
Key secondary outcomes
Cellular senescence-related markers, epigenetic markers, routine hematological and blood biochemical parameters, lifestyle factors, and subjective health assessment
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese males and females aged 40 to 69 years at the time of informed consent.
(2) Healthy adults.
(3) Individuals who have received a full explanation of the study objectives and procedures, have understood the study, voluntarily agreed to participate, and are able to provide written informed consent.
(4) Individuals who have continuously consumed Food X for at least 6 months.
(5) Individuals who agree to continue consuming Food X until the study assessment day.
Key exclusion criteria
(1) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period.
(2) Individuals diagnosed with or receiving treatment for specific diseases, including cancer, hematological disorders, or immune disorders.
(3) Individuals currently using specific medications, including anticancer drugs or immunosuppressive agents.
(4) Individuals with a history of gastrointestinal resection surgery (excluding appendectomy).
(5) Individuals who participated in another interventional study within 6 months prior to informed consent or who plan to participate in another interventional study during the study period.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Saito |
Organization
SOUKEN Co., Ltd.
Division name
None
Zip code
105-0013
Address
6F, Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1557
jimukyoku@mail.souken-r.co.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd.
Division name
Secretariat
Zip code
105-0013
Address
3F, Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.co.jp
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F, Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate the association between long-term consumption of Food X and biological age and gut environment.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072277
