UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055810 |
|---|---|
| Receipt number | R000063787 |
| Scientific Title | Validation study of test food effects on brain activity |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 09:00:58 |
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Basic information
Public title
Validation study of test food effects on brain activity
Acronym
Validation study of test food effects on brain activity
Scientific Title
Validation study of test food effects on brain activity
Scientific Title:Acronym
Validation study of test food effects on brain activity
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food on brain activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax
Key secondary outcomes
Electroencephalogram, Visual analog scale questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Single ingestion of the test food > Washout period > Single ingestion of the placebo food
Interventions/Control_2
Single ingestion of the placebo food > Washout period > Single ingestion of the test food
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy male/female subjects ranging in age from 18 to 39, at informed consent.
(2)Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
(3)Subjects who can visit the designated measurement days and receive the measurement.
Key exclusion criteria
Subjects
1) who have a habit of continuously taking drugs, foods with health claims (Foods with Nutritional Function Claims, Foods for Specified Health Uses, and Foods with Function Claims), health foods, or supplements that claim to maintain or promote cognitive function (At least 3 times/week for at least 1 month), currently or within the past 3 months, or those who plan to take them during the study period
2) whose sleeping timeframe fluctuate greatly, such as shift work
3) who may change their lifestyle habits during the study period (Changing jobs, moving, long trips, learning, etc.)
4) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in another clinical test
5) who may take medicine during the study period due to seasonal allergies (e.g., hay fever)
6) having a habit of smoking
7) with excessive alcohol intake
8) with lifestyle diseases (e.g., diabetes mellitus, hypertension, dyslipidemia) or diagnosed in the past
9) who has been diagnosed as having hyperglycemia through a medical examination
10) with neurological disorders such as dementia, stroke, Parkinson's disease, epilepsy, etc. (Excluding headaches and migraines)
11) who received medication for 1 month prior to obtaining consent or who plan to receive medication during the study period (Excluding history of taking medicine for headache, menstrual pain, cold, etc.)
12) with a past or current history of serious diseases (e.g., heart disease, cancer, renal failure)
13) who are pregnant, lactating or planning to become a pregnant during the study period
14) with sensitive skin to any coatings (e.g., drugs, quasi drugs, cosmetics), bath salts, tapes, etc., and those with wounds on the head (forehead, near mastoid process (behind ear))
15) with allergies to drug and/or food (including a history of these allergies) (especially milk and gelatin)
16) deemed unsuitable for participation in the trial by the principal investigator
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa Prefecture, 230-8504, Japan
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Setoguchi |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa Prefecture, 230-8504, Japan
TEL
045-571-6140
Homepage URL
y-setoguchi-ia@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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2025 | Year | 09 | Month | 17 | 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
16
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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063787
