UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060842 |
|---|---|
| Receipt number | R000066977 |
| Scientific Title | Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 09:36:47 |
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Basic information
Public title
Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness
Acronym
Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness
Scientific Title
Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness
Scientific Title:Acronym
Exploratory study evaluating the suppressive effect of the test food on daytime sleepiness
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a single intake of the test food on daytime sleepiness in comparison with the control food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maintenance of Wakefulness Test (MWT)
Key secondary outcomes
Karolinska Sleepiness Scale (KSS)
Microsleep Latency
Oguri-Shirakawa-Azumi Sleep Inventory, Middle-Aged and Aged version (OSA-MA)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of the test food on the day of the study
Interventions/Control_2
Single intake of the placebo food on the day of the study
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Adult male full-time employees of the Research Headquarters whose workplace is the Meiji Innovation Center at the time of obtaining consent.
2. Subjects who have received sufficient explanation about the purpose and content of this study, possess the capacity to consent, and have voluntarily agreed to participate after fully understanding the information provided.
Key exclusion criteria
1. Subjects currently receiving treatment (including medication) for any disease.
2. Subjects with a Body Mass Index (BMI) greater than 25.
3. Subjects whose usual sleep duration, calculated from self reported bedtime and wake up time, is less than 6 hours.
4. Subjects with suspected sleep disorders.
5. Subjects unable to comply with study procedures.
6. Subjects engaged in shift work, night work, or whose primary occupation involves physical labor.
7. Subjects who consume excessive amounts of alcohol (defined as consuming more than 1 go of sake [equivalent to one 500 mL bottle of beer, one double shot of whiskey, or 0.6 go of shochu] three or more times per week).
8. Subjects who smoke.
9. Subjects with known food allergies.
10. Subjects with lactose intolerance.
11. Subjects who self identify as caffeine dependent.
12. Subjects currently participating in or planning to participate in another clinical trial at the start of this study.
13. Subjects deemed inappropriate for participation by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kentarou |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
Nutrition and Food Function Group
Zip code
192-0919
Address
Meiji Innovation Center, 1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Kentarou |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
Nutrition and Food Function Group
Zip code
192-0919
Address
Meiji Innovation Center, 1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
Homepage URL
kentarou.nakamura@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. University of Tsukuba, International Institute for Integrative Sleep Medicine (WPI-IIIS)
2. S'UIMIN Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
7
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
| 2025 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066977
