UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062630 |
|---|---|
| Receipt number | R000071262 |
| Scientific Title | Effects of Test Food on Brain Function: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/18 14:32:22 |
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Basic information
Public title
Effects of Test Food on Brain Function: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial
Acronym
Effects of Test Food on Brain Function
Scientific Title
Effects of Test Food on Brain Function: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial
Scientific Title:Acronym
Effects of Test Food on Brain Function
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous consumption of test food on the maintenance and improvement of cognitive function in healthy young adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test
Key secondary outcomes
Electroencephalography (EEG); electrocardiography; flicker test; subjective psychological assessments; subjective sleep assessments; blood biomarkers (neurotrophic factors, liver function); and fecal organic acid analysis.
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
Oral consumption of the test food for 12 weeks
Interventions/Control_2
Oral consumption 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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 18 to 29 years at the time of informed consent.
2. Individuals whose native language is Japanese.
3. Individuals who are able to visit the study site on the designated dates and undergo the required examinations and assessments.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who are unable to complete the study assessments due to conditions that interfere with testing (e.g., color vision deficiency, injuries or diseases affecting computer operation, or inability to complete the assessments even with assistive devices such as eyeglasses or hearing aids).
2. Individuals with a current or past diagnosis of dementia, psychiatric disorders (including depression and sleep disorders), neurological disorders, or cerebrovascular diseases, or those suspected of having any of these conditions.
3. Individuals with chronic diseases, such as diabetes mellitus, hypertension, or dyslipidemia, who routinely take medications.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (e.g., products claiming benefits related to cognitive function).
5. Individuals who are taking medications that could affect the study, such as antibiotics, probiotics, medications for constipation, or laxatives and who are unable to restrict their use from the time of consent acquisition.
6. Individuals who consume foods rich in lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber (excluding fresh foods), Bacillus subtilis var. natto, or butyric acid-producing bacteria at least five times per week. Individuals who consume such foods less than five times per week are eligible, provided that they do not increase their intake frequency or amount during the study period.
7. Individuals who are participating in, have completed within the past four weeks, or are planning to participate in clinical trials of pharmaceuticals or health foods.
8. Individuals with excessive alcohol intake or alcohol dependence.
9. Smoker
10. Individuals with current and/or past serious diseases of the heart, liver, kidneys, digestive organs, or other organs.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shibaura Institute of Technology
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
| 2026 | Year | 08 | 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 | 07 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
11. Females who are pregnant, breastfeeding, or intending to become pregnant during the trial period.
12. Individuals with allergies to medications and/or foods.
13. Individuals with lactose intolerance or those who are aware that consumption of dairy products causes diarrhea.
14. Individuals who are aware that alcohol consumption causes diarrhea. However, individuals who do not habitually consume alcohol and who abstain from alcohol throughout the study period are eligible.
15. Individuals who frequently experience diarrhea.
16. Individuals who are aware that they are infected with viral hepatitis B or C, HIV, or syphilis.
17. Individuals who donated blood components or 200 mL of whole blood within the last month.
18. Male individuals who donated 400 mL of whole blood within the last 3 months.
19. Female individuals who donated 400 mL of whole blood within the last 4 months.
20. Male individuals whose blood collection volume in the last 12 months, combined with the planned volume of this study, exceeds 1200 mL.
21. Female individuals whose blood collection volume in the last 12 months, combined with the planned volume of this study, exceed 800 mL.
22. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071262
