UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060616 |
|---|---|
| Receipt number | R000068798 |
| Scientific Title | A randomized crossover controlled trial on the effects of Echizen cheese produced using lactic acid bacteria derived from Buckwheat in Fukui on sleep quality and gut microbiota. |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/08 12:13:44 |
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Basic information
Public title
Comparative study on the effects of Echizen cheese produced using Buckwheat-Derived lactic acid bacteria in Fukui on sleep quality and gut microbiota.
Acronym
Comparative study on the effects of Echizen cheese on sleep quality and gut microbiota.
Scientific Title
A randomized crossover controlled trial on the effects of Echizen cheese produced using lactic acid bacteria derived from Buckwheat in Fukui on sleep quality and gut microbiota.
Scientific Title:Acronym
A randomized crossover controlled trial on the effects of Echizen cheese on sleep quality and gut microbiota.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of consuming natural cheese containing Fukui Prefecture buckwheat-derived lactic acid bacteria on human sleep quality and gut microbiota.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each cycle will last 20 days, with questionnaire surveys using the OSA Sleep Questionnaire MA version conducted before and after the 14-day intervention period. After a 14-day break, the second cycle will replace the cheese and conduct the same intervention and questionnaire survey.
Key secondary outcomes
1) Over two 14-day periods (two cycles), sleep and wakefulness will be continuously measured using a wearable device for sleep tracking to compare changes in sleep quantity and quality before and after the intervention.
2) Four stool samples will be collected in total to compare changes in the gut microbiota before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Each cycle lasts 20 days. During the first 6 days, participants complete a sleep questionnaire and collect stool samples. After consuming Echizen cheese for the next 14 days, they complete another sleep questionnaire and collect stool samples. Following a 14-day washout period, the second cycle involves the same intervention using placebo cheese.
Interventions/Control_2
Each cycle lasts 20 days. During the first 6 days, participants complete a sleep questionnaire and collect stool samples. After consuming placebo cheese for the next 14 days, they complete another sleep questionnaire and collect stool samples. Following a 14-day washout period, the second cycle involves the same intervention using Echizen cheese.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of the Hokuriku region aged 18 or older
Individuals scoring 4 or higher on the Athens Insomnia Scale
Individuals who understand the content of this study and have provided written consent
Key exclusion criteria
Individuals with dairy allergies
Individuals with digestive disorders such as inflammatory bowel disease or irritable bowel syndrome
Individuals who regularly take laxatives
Individuals with dietary restrictions for medical or religious reasons
Individuals who regularly take sleeping pills or sleep aids, or those with sleep disorders such as sleep apnea
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | oshima |
Organization
Fukui Prefectural University
Division name
Faculty of Nursing & Social Welfare Sciences
Zip code
910-1195
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
TEL
0776-61-6000
oshima@g.fpu.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Hibi |
Organization
Fukui Prefectural University
Division name
Faculty of Bioscience and Biotechnology
Zip code
910-1195
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
TEL
0776-61-6000
Homepage URL
hibi@g.fpu.ac.jp
Sponsor or person
Institute
Fukui Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Fukui Prefectural University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui Prefectural University
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
Tel
0776-61-6000
hibi@g.fpu.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 09 | 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 | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068798
