UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061324 |
|---|---|
| Receipt number | R000070163 |
| Scientific Title | Evaluation of Biological Age using Salivary HSP70 and its Association with Frailty |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/20 16:19:11 |
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Basic information
Public title
Evaluation of Biological Age using Salivary HSP70 and its Association with Frailty
Acronym
Evaluation of Biological Age using Salivary HSP70 and its Association with Frailty
Scientific Title
Evaluation of Biological Age using Salivary HSP70 and its Association with Frailty
Scientific Title:Acronym
Evaluation of Biological Age using Salivary HSP70 and its Association with Frailty
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To cross-sectionally investigate the association between non-invasively collected salivary HSP70 concentration and frailty (physical, social, and psychological) as well as its components (physical function indicators). Additionally, to verify whether salivary HSP70 can serve as an indicator reflecting "Biological Age" independent of chronological age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary HSP70 concentration at the time of examination (measured by ELISA).
Key secondary outcomes
The following items at the time of examination:
1. Saliva volume
2. Gait function (walking speed, gait balance)
3. Motor function (one-leg standing, chair stand test)
4. Grip strength
5. Body composition, Blood pressure, Height
6. Facial skin information (VISIA)
7. Frailty-related questionnaires (Basic, Checklist, 11-item check, Izumo scale, Oral frailty self-check, etc.)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Japanese persons who are 18 years old or more at the time of consent.
3. Persons who can visit the measurement venue.
Key exclusion criteria
1. Persons with currently treated malignant tumors, severe heart failure or respiratory disease, chronic kidney disease requiring dialysis, or serious autoimmune diseases.
2. Persons currently receiving systemic steroid administration or immunosuppressant treatment.
3. Persons with obvious paralysis due to sequelae of cerebrovascular disease or those with neurodegenerative diseases.
4. Persons for whom walking or grip strength measurement is physically difficult due to acute fractures or joint diseases.
5. Persons with significant salivary secretion disorders such as Sjogren's syndrome.
6. Persons who have participated in other studies within one month before the start of the study, or those who intend to participate in another study after consenting to this study.
7. Persons judged as inappropriate by the principal investigator.
8. Persons who are pregnant or breastfeeding.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Noguchi |
Organization
Saishunkan Pharmaceutical Co., Ltd.
Division name
Research and Development Department
Zip code
861-2201
Address
1363-1 Jichu , Mashiki-machi, Kamimashiki-gun, Kumamoto, Japan
TEL
0962894444
tomoko.matsuda@saishunkan.co.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Noguchi |
Organization
Saishunkan Pharmaceutical Co., Ltd.
Division name
Research and Development Department
Zip code
861-2201
Address
1363-1 Jichu , Mashiki-machi, Kamimashiki-gun, Kumamoto, Japan
TEL
0962894444
Homepage URL
tomoko.matsuda@saishunkan.co.jp
Sponsor or person
Institute
Saishunkan Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Saishunkan Pharmaceutical Co., Ltd.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
0368092722
soumu@hc-sys.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 | 04 | 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 | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070163
