UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058858 |
|---|---|
| Receipt number | R000067308 |
| Scientific Title | A study to evaluate the effects of test food consumption on the improvement of health functions (brain function): a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/08/21 |
| Last modified on | 2025/08/21 14:02:35 |
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Basic information
Public title
A study to evaluate the effects of test food consumption on the improvement of health functions (brain function)
Acronym
A study to evaluate the effects of test food consumption on the improvement of health functions (brain function)
Scientific Title
A study to evaluate the effects of test food consumption on the improvement of health functions (brain function): a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to evaluate the effects of test food consumption on the improvement of health functions (brain function)
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on the improvement of cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the standardized score for Composite Memory on Cognitrax at 12 weeks after consumption (12w) [High-dose group vs. Placebo group; Low-dose group vs. Placebo group]
Key secondary outcomes
1. The measured values of the standardized scores for each cognitive domain (excluding Composite Memory) and each test result on Cognitrax at 12w
2. The measured values of low frequency (LF), high frequency (HF), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, total power (TP), coefficient of component variance total power (ccvTP), deviation value of autonomic nervous function, and autonomic functional age measured by VM302 at 12w
3. The measured values of d-ROMs, BAP, high-sensitivity CRP, ApoA-1, TTR, C3, IL-1 alpha, IL-1 beta, TNF alpha, IL-6, CXCL1, CXCL2, G-CSF, CCL5, testosterone, dihydrotestosterone, p-TAU217, amyloid beta 42, and NAD+ at 12w
4. The bacterial occupancy rate in feces and the alpha diversity index at 12w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Tablet containing high-dose S-allylcysteine (SAC) extract powder
Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not eat breakfast, take tablets in the morning.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test product: Tablet containing fermented SAC extract powder
Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not eat breakfast, take tablets in the morning.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_3
Duration: 12 weeks
Test product: Placebo
Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not eat breakfast, take tablets in the morning.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next 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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 45 or older and younger than 70
4. Healthy individuals
5. Individuals who are aware of a decline in memory
6. Individuals whose Mini Mental State Examination (MMSE) is 24 or higher at screening
7. Individuals whose validity indicators for both the Verbal Memory and Visual Memory Tests on Cognitrax are marked as "Yes" at screening
8. Individuals whose standardized score in Verbal Memory of Cognitrax is less than 100 at screening
Key exclusion criteria
Individuals who
1. are under treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are under treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. take "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. take or use medicines (including herbal medicines) or supplements
6. are allergic to medicines or foods related to the test product (particularly, onion, garlic chives, or garlic)
7. are pregnant, lactating, or planning to become pregnant during this study
8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. have dementia
10. have a history of mental disorder (e.g., depression or attention-deficit/hyperactivity disorder)
11. regularly consume foods with rich procyanidins (e.g., apples, black soybeans, cacao)
12. regularly consume foods or supplements that may affect cognitive function (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, plasmalogen)
13. consume blue-backed fish at least four times a week (e.g., sardines, mackerel, saury)
14. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games)
15. have irregular sleeping time or habit due to work (e.g., late-night shift)
16. are smokers or have quit smoking within the last three months before the agreement to participate in this study
17. consume alcohol excessively (>=60 g/day)
18. have irregular lifestyles (e.g., diet, exercise, sleep)
19. are judged as ineligible to participate in this study by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Bizen Chemical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Bizen Chemical 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067308
