UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063070 |
|---|---|
| Receipt number | R000072198 |
| Scientific Title | Effects of consumption of the test food on sleep in healthy Japanese: a randomized, placebo-controlled, single-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 10:36:47 |
* 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 on the effects of consumption of the test food on sleep in healthy Japanese
Acronym
Study on the effects of consumption of the test food on sleep in healthy Japanese
Scientific Title
Effects of consumption of the test food on sleep in healthy Japanese: a randomized, placebo-controlled, single-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on sleep 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 sleep quality 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. OSA sleep inventory MA version (OSA-MA)
Key secondary outcomes
1. Athens Insomnia Scale (AIS), Chalder Fatigue Scale (CFS), blood cytokines and metabolome analysis, Brief-type self-administered Diet History Questionnaire (BDHQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test product: Intervention food
Interventions/Control_2
Duration: Four weeks
Test product: Placebo
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. Japanese
2. Men or women
3. Individuals aged 20 or more and less than 65
4. Healthy individuals
5. Individuals whose mean standardized score (Zi) of the five factors of the OSA-MA is < 50
6. Individuals whose mean standardized score (Zi) of "Initiation and maintenance of sleep" of the OSA-MA is < 50
Key exclusion criteria
Individuals who
1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. have an implanted pacemaker or implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. consume Foods for Specified Health Uses or Foods with Functional Claims
5. are taking or using medications (including herbal medicines) or supplements, particularly those who regularly use anticoagulants such as warfarin
6. are allergic to medications or foods related to the test product (particularly, intervention food, placebo, or wheat)
7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
8. have irregular sleeping time or habit due to work such as a late-night shift
9. have irregular lifestyles (such as diet, exercise, and sleep)
10. sleep in a bed shared with multiple people
11. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome
12. work in physical labor such as transportation of heavy objects
13. cannot consume intervention food or placebo every day
14. consume intervention food and related foods at least four days per week
15. take food/beverage containing functional ingredients which may influence sleep quality
16. have allergy symptoms caused by pollen and regularly use medications
17. are pregnant, lactating, or planning pregnancy during this study
18. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
19. are deemed unsuitable for participation in this study by the principal investigator
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
Mizkan Holdings Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings 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
| 2026 | Year | 09 | Month | 28 | 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
| 2026 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072198
