UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054437 |
|---|---|
| Receipt number | R000061937 |
| Scientific Title | Trial to Evaluate the Effects of Single Dose Consumption of a Test Food on Brain Function |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/09/04 13:27:02 |
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Basic information
Public title
Trial to Evaluate the Effects of Single Dose Consumption of a Test Food on Brain Function
Acronym
Trial to Evaluate the Effects of Single Dose Consumption of a Test Food on Brain Function
Scientific Title
Trial to Evaluate the Effects of Single Dose Consumption of a Test Food on Brain Function
Scientific Title:Acronym
Trial to Evaluate the Effects of Single Dose Consumption of a 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 a single dose consumption of the test food on brain function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax (Symbol Digit Coding (SDC) Test, Stroop Test, Attention Shift Test)
Key secondary outcomes
Profile of Mood States 2 (POMS2) Japanese short version, Psychological questionnaire, Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Consumption of the test food
Interventions/Control_2
Consumption of the placebo 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 40 to below 60 years at the time of consent acquisition.
2. Subjects with a Body Mass Index (BMI) less than 25.0 kg/m2.
3. Non-smokers (no smoking in the past year).
4. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are continuously taking prescription medications and cannot discontinue their use during the trial period.
2. Subjects who consume Food for Specified Health Uses (FOSHU), Foods with Function Claims (e.g., GABA, Lactobacillus gasseri CP2305), or health food (including supplements) affecting the autonomic nervous system, stress, fatigue, and brain function at least once a week.
3. Subjects who cannot discontinue the consumption of Food for Specified Health Uses (FOSHU), Foods with Function Claims (e.g., GABA, Lactobacillus gasseri CP2305), or health food (including supplements) affecting the autonomic nervous system, stress, fatigue, and brain function during the trial period.
4. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
5. Subjects who have experienced significant life changes such as moving, changing jobs, or separation from close relatives within the last three months prior to consent acquisition, which could lead to high stress, or those likely to experience such events during the study period.
6. Subjects with extremely irregular eating habits or work schedules, including shift workers and night workers, who have irregular life rhythms.
7. Subjects who engage in excessive physical exercise routinely.
8. Subjects with excessive alcohol intake.
9. Subjects who find it difficult to abstain from alcohol from the day before the trial begins.
10. Subjects unsuitable for heart rate measurement due to issues such as dense chest hair, use of a pacemaker, or skin sensitivity on the chest area.
11. Subjects with severe symptoms of Premenstrual Syndrome (PMS).
12. Subjects with allergic rhinitis that may interfere with trial operations.
Target sample size
30
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
ASAHI QUALITY & INNOVATIONS, 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 | 05 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
13. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney, and/or digestive organs.
14. Females who are pregnant or lactating, and females who could become pregnant during trial period.
15. Subjects with allergies to medications and/or food.
16. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2024 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061937
