UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063091 |
|---|---|
| Receipt number | R000072225 |
| Scientific Title | Observational study on the evaluation of age-related biological changes in healthy individuals and their relationship with lifestyle habits |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/29 12:29:25 |
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Basic information
Public title
Observational study on the evaluation of age-related biological changes in healthy individuals and their relationship with lifestyle habits
Acronym
Observational study on the evaluation of age-related biological changes in healthy individuals and their relationship with lifestyle habits
Scientific Title
Observational study on the evaluation of age-related biological changes in healthy individuals and their relationship with lifestyle habits
Scientific Title:Acronym
Observational study on the evaluation of age-related biological changes in healthy individuals and their relationship with lifestyle habits
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between age-related changes in biological samples and lifestyle habits in healthy individuals.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between age-related changes in biological samples and lifestyle habits in healthy individuals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood and salivary measures and their association with lifestyle habits
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy male and female in their 20s and 60s.
2) Individuals with a body mass index (BMI) of 18.5 or higher and less than 25.0 kg/m2.
3) Individuals who received a full explanation of the purpose and content of this study, have the capacity to provide informed consent, fully understand the study, and voluntarily provide written informed consent to participate.
Key exclusion criteria
1) Individuals who received any vaccination within 3 months prior to the study visit.
2) Individuals with immune system disorders, diabetes mellitus, or kidney disease.
3) Individuals who are participating in another clinical study or trial before completion of the study procedures.
4) Individuals who donated blood within 1 month prior to the study visit.
5) Individuals who are considered unsuitable for participation in the study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Kirin Holdings Company, Limited
Division name
Kirin Central Research Institute
Zip code
2518555
Address
Shonan Health Innovation Park 12-12 26-1 Muraoka-Higashi 2-chome, Fujisawa, Kanagawa
TEL
080-2202-2921
Takahiro_Yamazaki@kirin.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Umeda |
Organization
Kirin Holdings Company, Limited
Division name
Kirin Central Research Institute
Zip code
2518555
Address
Shonan Health Innovation Park 12-12 26-1 Muraoka-Higashi 2-chome, Fujisawa, Kanagawa
TEL
090-2760-2988
Homepage URL
Kentaro_Umeda@kirin.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
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
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-7000
02976_Ni@kirin.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
医療法人財団健康睡眠会 日本橋循環器内科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | 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 | 25 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the association between age-related changes in biological samples and lifestyle habits in healthy individuals.
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072225
