UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057835 |
|---|---|
| Receipt number | R000065926 |
| Scientific Title | A study to evaluate the effect of the test product on cognitive function |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/01/05 17:48:09 |
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Basic information
Public title
A study to evaluate the effect of the test product on cognitive function
Acronym
A study to evaluate the effect of the test product on cognitive function
Scientific Title
A study to evaluate the effect of the test product on cognitive function
Scientific Title:Acronym
A study to evaluate the effect of the test product on cognitive function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study will be conducted to examine the effects of the components of the test product on cognitive function in Japanese males and females aged 20 to less than 60.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average reaction time in the selective reaction test and the multi-task attention allocation test
Key secondary outcomes
(Secondary outcomes)
Questionnaire of physical feeling
(Safety evaluation)
Vital signs, physical measurements (body weight, BMI), adverse events
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo beverage A on the day
Washout
Intake test beverage on the day
Washout
Intake placebo beverage B on the day
Interventions/Control_2
Intake test beverage on the day
Washout
Intake placebo beverage B on the day
Washout
Intake placebo beverage A on the day
Interventions/Control_3
Intake placebo beverage B on the day
Washout
Intake placebo beverage A on the day
Washout
Intake test beverage on the day
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 20 to less than 60 at the time of written informed consent.
2.Non-smokers. (no smoking in the last year)
3.Subjects who are able to 1 bottle of beer, totaling about 350mL
4.Subjects who hold Driver's License and drive a car regularly
5.Subject who is fully explained the purpose and details of the study, has ability to consent, is volunteering to participate in the study with a full understanding of the explanation, and has consented to participate in the study in writing.
Key exclusion criteria
1.Subject receiving medication or outpatient treatment for a serious disease.
2.Subject receiving exercise or diet therapy under the supervision of a physician.
3.Subject who has currently taking any products (e.g., foods for specified health use, foods with functional claims, dietary supplements or health foods, drugs, quasi-drugs) that can affect the autonomic nervous system, metabolism, or sleep, and are unable to discontinue taking them during the study period.
4.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past.
5.Subject with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc.
6.Heavy drinker.
7.Subject who has difficulty quitting drinking from the day before the test date.
8.Subject who has extremely irregular eating habits, those who have an extremely irregular rhythm of life, such a those who work in shifts or late at night.
9.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study.
10.Subject who is aware of frequent urination
11.Subject with severe PMS (premenstrual syndrome) symptoms.
12.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
13.Subject who has difficulty in evaluating flavors and aromas because of conditions such as allergic rhinitis.
14.Subject who is allergic to medicines or food.
15.Subject with current or former drug or alcohol dependence.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirota |
Organization
Asahi Quality & Innovations, Ltd
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-21,MIDORI 1-CHOME, MORIYA-SHI, IBARAKI,302-0106
TEL
0297-46-4064
tatsuhiko.hirota@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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 | 05 | Month | 12 | 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
45
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 | 04 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 25 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 26 | Day |
Other
Other related information
(Exclusion criteria continued)
16.Subject who has constitutionally incapable of drinking alcohol.
17.Subjects who do not like beer,shochu,or carbonated beverages
18.Subject who unable to comply during the study period.
19.Subject whose various test results at screening (Visit 1) indicate their ineligibility to participate in the study.
20.Subject who the Co-Investigator(investigator) has determined that participation in this study is inappropriate.
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065926
