UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057203 |
|---|---|
| Receipt number | R000065383 |
| Scientific Title | Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/03/04 |
| Last modified on | 2026/01/13 17:06:31 |
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Basic information
Public title
Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on cognitive function in healthy Japanese
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 consumption of the test food on cognitive function in healthy Japanese
Basic objectives2
Safety,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 of verbal memory at 12 weeks after intervention (12w)
Key secondary outcomes
1. The change and percentage change from screening (before intervention; Scr) of the standardized score of verbal memory at 12w
2. The measured values of the standardized scores of each cognitive domain {neurocognition index (NCI), composite memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention, and motor speed} at 12w, and the changes and percentage changes of them from Scr
3. The measured value of blood flow at 12w
4. The measured values of "eye fatigue," "coldness of fingertips," "coldness of whole body," "shoulder and neck stiffness," "facial swelling," "leg swelling," "sleepiness," "stress," "fatigue," "mouth dryness", and "skin dryness" measured by visual analogue scale (VAS) 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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Four candies per day containing Okinawan brown sugar
Interventions/Control_2
Duration: 12 weeks
Four candies per day not containing Okinawan brown sugar
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 40 or more
4. Healthy individuals
5. Individuals who notice a decline in memory
6. Individuals whose scoring of the Mini Mental State Examination (MMSE) is 24 or more at Scr
7. Individuals who have a "yes" in the validity indicator of the Cognitrax on both verbal memory and visual memory at Scr
8. Individuals who have a low standardized score in verbal memory of the Cognitrax at Scr
Key exclusion criteria
Individuals who
1.are under medical 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 medical treatment for 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 medications (including herbal medicines) or supplements
6. are allergic to medicines and foods related to the test product, particularly who show allergic reactions to brown sugar and sugarcane
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 depression, attention-deficit/hyperactivity disorder, or other psychiatric disorders
11. usually take foods or supplements that may affect cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, or plasmalogen
12. take blue-backed fish such as sardines, mackerel, or saury at least four times per week
13. use devices, equipment, and applications that may affect cognitive functions (such as brain training puzzles or brain training games)
14. have irregular sleeping time or habit due to work such as a late-night shift
15. are smokers or have quit smoking within 3 months before agreeing to participate
16. usually drink more than 60 g/day of alcohol
17. have irregular lifestyles (such as diet, exercise, or sleep)
18. have pollen allergy
19. are judged as ineligible to participate in this study by the physician
Target sample size
60
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
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Kasugaiseikahanbai CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
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 | 03 | Month | 04 | 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
68
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 | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 09 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065383
