UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058210 |
|---|---|
| Receipt number | R000066542 |
| Scientific Title | Study of effects on cognitive function by the intake of research food |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/06/20 11:56:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of effects on cognitive function by the intake of research food
Acronym
Study of effects on cognitive function by the intake of research food
Scientific Title
Study of effects on cognitive function by the intake of research food
Scientific Title:Acronym
Study of effects on cognitive function by the intake of research food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of continuous intake of the research food for 8 weeks on cognitive function, using a placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MIREVO, Cognitrax long
Key secondary outcomes
OSA-MA, SMH, Fatigue VAS, POMS2
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the research food once a day, 1 piece for 8 consecutive weeks
Interventions/Control_2
Intake the placebo once a day, 1 piece for 8 consecutive weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Working generation males and females of from 20 to 64 years of age
(2) Subjects who are dissatisfied with their sleep and aware of fatigue, and feel a decline in their performance (concentration, attention, etc.) in their daily lives
(3) Subjects who have relatively low Cognitrax attention scores at the pre-test.
(4) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who have difficulty distinguishing colors
(2) Subjects who suspected of having dementia
(3) Subjects who have difficulty in evaluating cognitive function tests
(4) Subjects who suspected of having depression/major depressive disorder
(5) Subjects whose sleeping environment, bedtime, and wake-up time are irregular during the study period
(6) Subjects who engaged in manual labor such as transporting heavy objects
(7) Subjects who have nocturia, benign prostatic hyperplasia, or overactive bladder
(8) Subjects who engage in activities that affect cognitive function, sleep, fatigue, concentration, or attention
(9) Subjects who are using medicines that affect cognitive function, sleep, fatigue, concentration, and attention
(10) Subjects who are currently taking health foods related to cognitive function, sleep, fatigue, concentration, and attention, as well as those who plan to take them
(11) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study
(12) Subjects who may develop allergies in relation to the study
(13) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication, and those who are scheduled for surgery
(14) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
(15) Subjects who work in shifts, work late at night, and have an irregular daily rhythm
(16) Subjects who are participating in the other study at the start of this study
(17) Subjects who plan to become pregnant or breastfeed during the study period
(18) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(19) Subjects who are judged as unsuitable for the study by the principal investigator for other reason
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Tatsuji |
| Middle name | |
| Last name | Takahashi |
Organization
ICHIMARU PHARCOS Co., Ltd.
Division name
Research and Development Divison
Zip code
501-0475
Address
318-1 Asagi, Motosu-Shi, Gifu
TEL
058-320-1030
support@ichimaru.co.jp
Public contact
Name of contact person
| 1st name | Rio |
| Middle name | |
| Last name | Fujiwara |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
07070798488
Homepage URL
fujiwara.rio605@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.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
医療法人社団 幸和会 幸和クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Various statistical analyses, such as stratified and subgroup analyses, may be performed for the purpose of confirming the strength of the effect of the research food on employment status, test scores, etc.
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066542
