UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052244 |
|---|---|
| Receipt number | R000059636 |
| Scientific Title | Cross-sectional observational study for the relationships between specific body condition and immune function in the healthy elderly subjects |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2025/03/28 09:45:27 |
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Basic information
Public title
Study for immune function in the healthy elderly subjects
Acronym
Study for the immune function in the elderly subjects
Scientific Title
Cross-sectional observational study for the relationships between specific body condition and immune function in the healthy elderly subjects
Scientific Title:Acronym
Cross-sectional observational study for the relationships between specific body condition and immune function in the elderly subjects
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between specific body condition and immune function in the healthy elderly subjects.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of specific immune cells
Key secondary outcomes
The ratio of other immune cells, Blood biochemistry test, Scoring of specific body condition, Subject's background questionnaire
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male and Female more than 65 years old, when giving the informed consent.
2. Individuals not certified as Care/Support Need.
3. Individuals who were scored 0 or over 2 by the J-CHS criteria
4. Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5. Individuals who can accomplish their tasks in the study at the appointed date
6. Individuals who are judged suitable for this study by the investigator.
7. Individuals who can understand Japanese
Key exclusion criteria
1. Individuals who are a patient of chronic disease such as diabetes, and mental illness such as Alzheimer's disease and dementia.
2. Individuals who are a patient of chronic inflammatory disease, autoimmune disease, cardiovascular disease, bowel disease, and immunologic disease.
3. Individuals who are a patient of or have a history of malignant.
4. Individuals who reject disclosing biological sex.
5. Individuals who intake alcohol drinks and exercise excessively on the test day and the day before the test day.
6. Individuals who have a smoking habit.
7. Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mitsuo |
| Middle name | |
| Last name | Maruyama |
Organization
National Center for Geriatrics and Gerontology
Division name
GeroScience Research Center
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
michan@ncgg.go.jp
Public contact
Name of contact person
| 1st name | keiko |
| Middle name | |
| Last name | Onishi |
Organization
National Center for Geriatrics and Gerontology
Division name
GeroScience Research Center
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
Homepage URL
keiko-o@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
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
Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi
Tel
0562-46-2311
IRB@ncgg.go.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
国立研究開発法人 国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 19 | 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
141
Results
A relationship has been confirmed between aging and decreased immune function.
Results date posted
| 2025 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1.Male and Female more than 65 years old, when giving the informed consent.
2.Individuals not certified as Care Need.
Participant flow
Adverse events
None
Outcome measures
･The ratio of specific immune cells
･Blood biochemistry test
･Scoring of specific body condition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059636
