UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059042 |
|---|---|
| Receipt number | R000067537 |
| Scientific Title | Evaluation study on the effects of the test food on cognitive function |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/27 11:59:47 |
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Basic information
Public title
Evaluation study on the effects of the test food on cognitive function
Acronym
Evaluation study on the effects of the test food on cognitive function
Scientific Title
Evaluation study on the effects of the test food on cognitive function
Scientific Title:Acronym
Evaluation study on the effects of the test food on cognitive function
Region
| Japan |
Condition
Condition
Healthy participant
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous consumption of the test food on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax
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 weeks
Interventions/Control_2
Ingestion of the placebo food for 12 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy male or female participants aged 40 to 69 years at the time of informed consent
2) Participants who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail
Key exclusion criteria
Participants
1) who are currently receiving medication for any illness
2) who have or are being treated for dementia or other memory impairment disorders
3) who have routinely taken medication for disease treatment within the past month (excluding as-needed use for headache, menstrual pain, cold, etc.)
4) with a past or current history of serious disorders of the liver, kidney, heart, lung, blood, etc.
5) with concurrent or past gastrointestinal diseases (except for past diseases judged by the principal investigator not to affect participation in the study)
6) with food allergies (including a history of these allergies, especially milk and soy)
7) who are pregnant, lactating, or planning to become a pregnant during the study period
8) with alcoholism or other psychiatric disorders
9) who currently smoke
10) who may change their daily lifestyle habits during the study period (e.g., moving, night shift work, long trips, etc.)
11) who may develop seasonal allergic symptoms (e.g., hay fever) during the study period
12) who have a habit of continuously consuming foods with health claims (e.g., Foods for Specified Health Uses, and Foods with Function Claims), health foods, or supplements that claim to have effects on cognitive function, currently or within the past three months, or those who plan to take them during the study period
13) who currently or within the past three months have routinely taken drugs labeled or claimed to have effects on cognitive function
14) who have received inpatient medical treatment within the past six months, or who are expected to be hospitalized during the study period
15) who participated in another clinical study within the past one month, or who plan to participate in another clinical study during the study period
16) judged by the principal investigator to be unsuitable for study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa Prefecture
TEL
045-571-6140
s-mori-ab@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa Prefecture
TEL
045-571-6140
Homepage URL
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 30 | 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
57
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
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067537
