UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057063 |
|---|---|
| Receipt number | R000065214 |
| Scientific Title | Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2026/06/07 08:01:34 |
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Basic information
Public title
Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects
Acronym
Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects
Scientific Title
Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the cognitive function in middle-aged and older Japanese subjects
Region
| Japan |
Condition
Condition
Healthy middle-aged and older Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the cognitive function in Japanese men or women aged 50 or more
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Cognitrax
Key secondary outcomes
1.Quality of life(POMS2, OSA-MA)
2.Safety assessment (blood tests, adverse events)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test food: Nucleotide containing capsule
Administration: Take one capsule per day
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within
Interventions/Control_2
Duration: 24 weeks
Test food: Placebo capsule
Administration: Take one capsule per day
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects with an MMSE score of 24 to 27 at screening and a Cognitrax standardized score of 60 to 90 for composite memory
2) Age: 50 years or older
3) Gender: Any
4) Non-smokers
5) Subjects who do not regularly consume foods designated for specified health uses, foods with functional claims, or other foods/drinks that may have functional properties
6) Subjects who do not consume foods or supplements that may affect cognitive function, such as DHA/EPA, ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, plasmalogen, etc.
7) Subjects who do not consume blue fish such as sardines, mackerel, or pacific saury for more than 4 days a week
8) Subjects who do not use tools, equipment, apps, etc. that may affect cognitive function (e.g. brain training puzzles, brain training games, etc.)
9) Subjects who do not regularly use medicines (including herbal medicines)
10) Subjects who do not suffer from lifestyle-related diseases (diabetes, etc.), rheumatism, liver disorders, kidney disorders, or other chronic diseases.
11) Subjects who do not suffer from dementia.
12) Subjects who do not have irregular sleep hours or sleep habits due to night shifts, etc.
13) Subjects who do not have a history of mental illness such as depression or attention deficit hyperactivity disorder (ADHD).
14) Subjects who are currently undergoing treatment for or have a history of malignant tumors, heart failure, or myocardial infarction.
15) Subjects who do not have a pacemaker or implanted cardioverter defibrillator.
16) Subjects who have no history of allergies to medicines.
17) Subjects who are not visiting a hospital or taking medication for the purpose of treatment.
18) Subjects who fully understand the contents of the clinical trial and have given written consent.
Key exclusion criteria
1) Pregnant or breastfeeding women or those who intend to become pregnant during the study period
2) Subjects who are participating in other clinical trials or studies, or those who have participated in other clinical trials or studies within the past 3 months
3) Subjects who are unable to follow the instructions of the doctor in charge or the medical institution staff
4) Subjects who are judged by the study administrator to have some kind of problem
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Hashiya |
Organization
Kanyukai clinic
Division name
Head
Zip code
553- 0004
Address
2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
TEL
06-6444-7788
hashiya@carna-medsalon.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Fukaya |
Organization
Tashikani Plus Co., Ltd
Division name
CEO
Zip code
530-0041
Address
6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
TEL
06-6352-6622
Homepage URL
fukaya@tashikani.jp
Sponsor or person
Institute
Tashikani Plus Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
YAMASA CORPORATION
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
Japan Food Evidence Association
Address
7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
Tel
06-6352-6622
info@food-evidence.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
寬友会クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 05 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065214
