UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059114 |
|---|---|
| Receipt number | R000067063 |
| Scientific Title | A Study on the Visualization of Biological and Psychosocial Aging Adapted for Japanese Individuals |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 17:32:15 |
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Basic information
Public title
Research on Visualizing Biological and Psychosocial Aging
Acronym
Research on Visualizing Biological and Psychosocial Aging
Scientific Title
A Study on the Visualization of Biological and Psychosocial Aging Adapted for Japanese Individuals
Scientific Title:Acronym
A Study on the Visualization of Biological and Psychosocial Aging Adapted for Japanese Individuals
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Construction of a Comprehensive Assessment System for Aging Incorporating Both Biological and Psychosocial Aspects in Japanese Populations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation consists of two components: biological age and psychosocial aging rate. To assess aging from physiological perspectives, we measure aging-related proteins in blood samples using ELISA method and statistically analyze their relationships with the indicators.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood sampling from healthy subjects for research purposes
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nationality/Birth: Japanese individuals born in Japan with both parents also born in Japan
Health Status:
No grade D or higher findings in health checkups within the past year
Mild abnormalities up to grade C acceptable if not on medication
Daily Living: Independent in ADL, capable of responding to questionnaires in Japanese
Consent: Able to provide written informed consent
Key exclusion criteria
Blood collection: Difficulty with blood collection, history of severe vasovagal reaction
Other study participation: Participation within past 3 months, planned participation during study period
Pregnancy/Lactation: Currently pregnant or breastfeeding
Medical history: History of alcohol or drug dependence
Blood transfusion: Transfusion within past 6 months
Other: Deemed inappropriate by principal investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Shiratori |
Organization
NEC Solution Innovators, Ltd.
Division name
Innovation Laboratories
Zip code
136-8627
Address
1-18-7 Shinkiba, Koto-ku, Tokyo 136-0082, Japan
TEL
03-5534-2746
iku-shiratori@xc.jp.nec.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shiga |
Organization
NEC Solution Innovators, Ltd.
Division name
Innovation Laboratories
Zip code
136-8627
Address
1-18-7 Shinkiba, Koto-ku, Tokyo 136-0082, Japan
TEL
03-5534-2746
Homepage URL
t-shiga@abc.jp.nec.com
Sponsor or person
Institute
NEC Solution Innovators, Ltd.
Innovation Laboratories
Institute
Department
Personal name
Funding Source
Organization
NEC Solution Innovators, Ltd.
Innovation Laboratories
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
NEC Ethical Review Committee for the Life Sciences
Address
7-1, Shiba 5-chome Minato-ku, Tokyo
Tel
03-3798-9520
rinri-shinsa@quality.jp.nec.com
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 | 17 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 27 | 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 | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067063
