UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059256 |
|---|---|
| Receipt number | R000067649 |
| Scientific Title | Verification of the Effects of a Single Dose of a Test Food on Psychological Effects |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/04/28 17:26:50 |
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Basic information
Public title
Verification of the Effects of a Single Dose of a Test Food on Psychological Effects
Acronym
Verification of the Effects of a Single Dose of a Test Food on Psychological Effects
Scientific Title
Verification of the Effects of a Single Dose of a Test Food on Psychological Effects
Scientific Title:Acronym
Verification of the Effects of a Single Dose of a Test Food on Psychological Effects
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the psychological changes induced by single dose consumption of the test food product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological questionnaire
Key secondary outcomes
Heart rate
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
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 to below 40 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of less than 30.0 kg/m2.
3. Individuals with no smoking history (for at least one year).
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 adhere to the trial protocol during the study period.
2. Individuals who are consuming Foods for Specified Health Uses, Foods with Function Claims, or health supplements (including supplements) that may affect the autonomic nervous system, metabolism, or sleep, and who cannot discontinue their use during the study period.
3. Individuals who are taking medications or quasi-drugs that may affect the autonomic nervous system, metabolism, or sleep, and who cannot discontinue their use during the study period.
4. Individuals who are participating in other clinical trials, who have participated in other clinical trials within 4 weeks prior to the current trial, or who plan to participate in other clinical trials at the time of consent acquisition.
5. Individuals who have experienced significant life changes (e.g., moving, changing jobs, or separation from close relatives) within 3 months prior to consent acquisition, which could lead to high stress, or those who are likely to experience such events during the study period.
6. Individuals with irregular lifestyles (including those with highly irregular meal times, shift workers, and night workers).
7. Individuals who routinely engage in excessive physical exercise.
8. Individuals with excessive alcohol intake.
9. Individuals who are physiologically unable to consume alcohol.
10. Individuals who dislike non-alcoholic beer, beer, or beer flavor.
11. Individuals who are unable to abstain from alcohol starting from the day before the trial.
12. Individuals with severe symptoms of premenstrual syndrome (PMS).
13. Individuals with a current or past history of drug or alcohol dependence.
14. Individuals with allergic rhinitis that may interfere with trial procedures.
15. Individuals who are under medical supervision for dietary or exercise therapy.
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
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
| 2026 | Year | 10 | Month | 01 | 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
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
16. Individuals who are currently receiving treatment for, or who have a history of, mental disorders (such as depression) or sleep disorders.
17. Individuals with a history of, or a current diagnosis of, diabetes or serious diseases affecting the heart, liver, kidneys, digestive system, or brain.
18. Individuals who are unsuitable for heart rate measurement due to factors such as dense chest hair, use of a pacemaker, or skin sensitivity in the chest area.
19. Females who are pregnant or lactating, or who could become pregnant during the trial period.
20. Individuals with allergies to medications or food.
21. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067649
