UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062466 |
|---|---|
| Receipt number | R000071496 |
| Scientific Title | Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/04 16:57:53 |
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Basic information
Public title
Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu
Acronym
Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu
Scientific Title
Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu
Scientific Title:Acronym
Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively evaluate changes in cognitive function scores, physical and daily function (frailty) scores, and blood protein profiles (proteomics analysis) before and after intervention in senior citizens who are aware of a decline in their own cognitive and physical functions, by having them ingest tablet-shaped test foods containing Kyushu-derived functional ingredients for a certain period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function assessment (MCI diagnostic tool "Brain Health Check") and blood test (proteomics analysis (SomaScan)) at baseline and after 16 weeks of intake.
Key secondary outcomes
Physical and living function (frailty) assessment (questionnaire), motor function measurement (grip strength, walking speed, gait, reactivity test, standing up, standing on one leg), body composition, saliva test (saliva volume, salivary HSP70 level), blood test (general blood test, blood ANGPTL2, blood HSP70), physical examination (body weight, BMI, blood pressure), subjective findings (daily diary, etc.), and objective findings (interview, etc.) at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks after start of intake.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Test Group A: Daily intake of the control diet (dextrin tablets) for 4 months.
Interventions/Control_2
Test Group B: Daily intake of the test diet (supplement containing Tamogidake) for 4 months.
Interventions/Control_3
Test Group C: Daily intake of the test diet (supplement containing Tsurureishi) for 4 months.
Interventions/Control_4
Test Group D: Daily intake of the test diet (supplement containing Tamogidake and Tsurureishi) for 4 months.
Interventions/Control_5
Test Group D: Daily intake of the test diet and mild exercise intervention for 4 months.
Interventions/Control_6
Exercise group: Mild exercise intervention for 4 months.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | 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 60 years old or more at the time of obtaining consent.
3. Persons who can come to the measurement site.
Key exclusion criteria
1. Persons who are diagnosed with dementia.
2. Persons who currently have malignant tumors (cancer) under treatment, severe heart failure/respiratory disease, chronic kidney disease requiring dialysis, or severe autoimmune disease.
3. Persons who take either diabetes medication or immunosuppressive agents.
4. Persons who have obvious paralysis due to sequelae of cerebrovascular disease (such as stroke), or have neurodegenerative diseases such as Parkinson's disease.
5. Persons who have physical difficulty in walking or measuring grip strength due to acute fractures or joint diseases.
6. Persons who have participated in other studies within 1 month before the start of the study, or who plan to participate in another study after consenting to this study.
7. Persons who are judged as inappropriate for study participants by the principal investigator.
8. Persons who are pregnant or breastfeeding.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Furusawa |
Organization
Saishunkan Pharmaceutical Co., Ltd.
Division name
Research and Development Department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
096-289-4444
c.furusawa@saishunkan.co.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Furusawa |
Organization
Saishunkan Pharmaceutical Co., Ltd.
Division name
Research and Development Department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
096-289-4444
Homepage URL
c.furusawa@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
03-6809-2722
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 | 08 | Month | 04 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071496
