UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058493 |
|---|---|
| Receipt number | R000066874 |
| 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 | 2025/07/16 |
| Last modified on | 2025/07/16 18:23:12 |
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Basic information
Public title
Effects of consumption of the test food on cognitive function in healthy Japanese
Acronym
Effects of consumption of the test food on cognitive function in healthy Japanese
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
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 amount and percentage of change of the standardized score of Verbal Memory from screening (Scr) to 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 amount and percentage of changes of them from Scr
3. The measured values of Physical Component Summary (PCS), Mental Component Summary (MCS), Role/Social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VTPF), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) 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
Test product: Tablet containing ripened Korean red ginseng extract powder
Administration: Take three tablets per day at any time during the day.
*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 not containing ripened Korean red ginseng extract powder
Administration: Take three tablets per day at any time during the day.
*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
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 are aware of a decline in memory (e.g., difficulty finding or recalling words)
6. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at Scr
7. Individuals whose validity indicator for Verbal Memory on Cognitrax is marked as "yes" at Scr
8. Individuals whose standardized score of Verbal Memory on Cognitrax is less than 90 at Scr
Key exclusion criteria
Individuals who
1. under treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. under treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. have dementia
5. have a history of mental health issues (e.g., depression disorder, attention deficit/hyperactivity disorder), reflux esophagitis, HIV, mitochondrial toxicity, long-term hepatitis C liver disease, hypercholesterolemia, chronic renal failure, valve replacement surgery, coronary artery stent, or gastric bypass surgery
6. need to take antipyretic analgesic (e.g., acetaminophen or ibuprofen) for a long term
7. take a large amount of caffeine (more than 3~4 cups a day)
8. are smokers or have not completed one year since starting to quit smoking
9. take "Foods for Specified Health Uses" or "Foods with Functional Claims"
10. take supplements or foods that may be related to improving cognitive functions (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogen)
11. take blue-backed fish (e.g., sardines, mackerel, or saury) at least four times a week
12. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games)
13. take or use medicines (including herbal medicines) or supplements
14. are allergic to medicines or foods related to the test food (particularly ginseng (Korean ginseng))
15. are pregnant, lactating, or planning to become pregnant during this study
16. 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
17. 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
KIM's Korean Ginseng Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KIM's Korean Ginseng 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 | 07 | Month | 16 | 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 | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 13 | 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 | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066874
