UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062376 |
|---|---|
| Receipt number | R000071318 |
| Scientific Title | A study evaluating the effects of test foods on immunosenescent cells |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/29 10:14:42 |
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Basic information
Public title
A study evaluating the effects of test foods on immunosenescent cells
Acronym
A study evaluating the effects of test foods on immunosenescent cells
Scientific Title
A study evaluating the effects of test foods on immunosenescent cells
Scientific Title:Acronym
A study evaluating the effects of test foods on immunosenescent cells
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the test food on immunosenescent cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cell surface markers and intracellular markers in immune cells, Scores of POMS 2 Brief Form, Subjective Cognitive Decline Questionnaire (SCD-Q) score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 12 consecutive weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 40 to under 65 at the time of informed consent.
2)Participants with advanced immunosenescence.
3)Participants who received a full explanation of the study and signed the informed consent form before study initiation.
Key exclusion criteria
1) Participants with a history of gastrointestinal resection surgery (excluding appendectomy).
2) Participants with a serious disease under treatment, or a history of a serious disease requiring pharmacological treatment.
3) Participants with autoimmune diseases (e.g., Graves' disease, rheumatoid arthritis, Hashimoto's thyroiditis, type 1 diabetes mellitus, systemic lupus erythematosus, polymyositis, Sjogren's syndrome, and systemic sclerosis), or a history thereof.
4) Participants with psychiatric disorders (e.g., depression), chronic fatigue syndrome, insomnia, or a history thereof.
5) Participants engaged in irregular work schedules, shift work, or physically demanding labor.
6) Participants regularly using medications, FOSHU, dietary supplements, or other health foods that may affect study outcomes.
7) Participants considered at risk of allergic reactions related to the study.
8) Participants with excessive alcohol consumption (average pure alcohol intake >=60 g/day) or current smokers.
9) Participants planning overseas travel or domestic travel lasting >=1 week during the study period.
10) Participants who participated in another clinical trial or research study within 3 months before informed consent, or who plan to participate in another study during the study period.
11) Participants who donated >200 mL of whole blood within 1 month before informed consent, or >400 mL of whole blood and/or blood components within 3 months before informed consent.
12) Participants who are pregnant, breastfeeding, or may become pregnant during the study period.
13) Participants considered unlikely to comply with study procedures, questionnaires, or study records.
14) Participants judged unsuitable based on clinical laboratory values or other screening results.
15) Participants suspected of having an infectious disease based on screening results, including HBV, HCV, syphilis, HTLV, or HIV infection.
16) Other participants judged unsuitable by the investigator.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Adachi |
Organization
FANCL CORPORATION
Division name
Clinical Research Center, Functional Food Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama-shi, Kanagawa, 244-0806, Japan
TEL
045-820-3846
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Tokyo Haneda Watanabe Clinic
Address
1-6-15,Haneda,Otaku,Tokyo,Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 糺榮会 東京羽田渡辺クリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 29 | 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
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071318
