UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053022 |
|---|---|
| Receipt number | R000060465 |
| 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 | 2023/12/06 |
| Last modified on | 2024/07/03 14:01:40 |
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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. Cognitrax at 12 weeks after consumption (12w)
Key secondary outcomes
1. Mini Mental State Examination (MMSE) at 12w
2. Salivary testosterone at 12w
3. Total testosterone and free testosterone 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
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Active food
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo food
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged between 40 and 70
4. Healthy individuals
5. Individuals whose scoring of MMSE is 24 or more at screening (before consumption; Scr)
6. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr
7. Individuals who have relatively low standardized score in composite memory measured using Cognitrax at Scr among those meeting No.1~6 of the inclusion criteria and not meeting the exclusion criteria
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, autoimmune disease, hemorrhagic disease, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking medications, herbal medicines, or supplements
6. are allergic to medicines and/or the test food related products
7. are pregnant, lactating, or planning to become pregnant during the study
8. have been enrolled in other clinical studies within 28 days before agreeing to participate or plan to participate another study during the study
9. have dementia
10. have a medical history of mental disorder (e.g., depression disorder, attention deficit/hyperactivity disorder)
11. usually take procyanidins-rich foods (e.g., apple, black soybean, cacao)
12. usually take foods or supplements that may affect cognitive functions (e.g., DHA, EPA, ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, plasmalogen)
13. take blue-backed fish (e.g., sardines, mackerel, saury) at least 4 times a week
14. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles or games)
15. have irregular sleeping time or habit due to night shift or other reasons
16. are smokers or have quit smoking within 3 months before agreeing to participate
17. usually drink more than 60 g/day of alcohol
18. have irregular lifestyles (e.g., diet, exercise, sleep)
19. have pollen allergy
20. may undergo surgery (including tooth extraction, endoscopic examination, or others) during the study or within 4 weeks after the end of consumption
21. are judged as ineligible to participate 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
DKS 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
| 2023 | Year | 12 | Month | 06 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060465
