UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056913 |
|---|---|
| Receipt number | R000065045 |
| Scientific Title | An exploratory study on the effect of food containing plant extract on sleep |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/04/17 16:33:17 |
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Basic information
Public title
An exploratory study on the effect of food containing plant extract on sleep
Acronym
An exploratory study on the effect of food containing plant extract on sleep
Scientific Title
An exploratory study on the effect of food containing plant extract on sleep
Scientific Title:Acronym
An exploratory study on the effect of food containing plant extract on sleep
Region
| Japan |
Condition
Condition
NO
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of food containing plant extract on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep latency in 4th week of intake, WASO in 4th week of intake
Key secondary outcomes
Other sleep index, Questionnaire
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing low-dose plant extract
Interventions/Control_2
Food containing medium-dose plant extract
Interventions/Control_3
Food containing high-dose plant extract
Interventions/Control_4
Food not containing plant extract
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
Key inclusion criteria
1.Subjects who can make self-judgment and are voluntarily giving written informed consent.
2.Healthy Japanese males aged 20 to 64 years-old.
3. Healthy subjects who attend school/work on weekdays, have no significant fluctuations in their daily bedtime/wake time, and are suspected of having sleep problems based on a preliminary questionnaire survey.
Key exclusion criteria
Subjects (who)
1.are currently attending a hospital or have a current medical history.
2.have been diagnosed as insomnia and have taken insomnia medications (including OTC medications or prescribed medications).
3.have been diagnosed with a mood disorder, including depression, and have taken medications to treat the disorder.
4.regularly use medications (except vitamins).
5.are unable to stop taking sleep-related supplements, functional foods, etc. during the study period.
6.are unable to stop consuming alcohol 4 hours or more before bedtime or caffeinated beverages 6 hours or more before bedtime during the test period.
7.work shift work, late-night work, or heavy labor.
8.are asked to report their normal bedtime and waking time, and whose bedtime is less than 6 hours.
9.consume excessive amounts of alcohol.
10.are pregnant, lactating, or intend to become pregnant
11.are living with a person who requires nursing care.
12. are unable to sleep alone on a bed or futon during the study period (two or more persons sleeping in the same room is acceptable).
13.are allergic to the test food.
14.are participating or will participate in other clinical trials at the start of this study.
15. are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | KINYA |
| Middle name | |
| Last name | TAKAGAKI |
Organization
TOYO SHINYAKU Co.,Ltd.
Division name
Executive Vice President
Zip code
841-0005
Address
7-28 Yayogaoka, Tosu City, Saga
TEL
+81-942-81-3560
rinsyo.umin@toyoshinyaku.co.jp
Public contact
Name of contact person
| 1st name | Chiemi |
| Middle name | |
| Last name | Tanigawa |
Organization
S'UIMIN INC.
Division name
Research Support Division
Zip code
151-0061
Address
817, Hatsudai Center Bldg. 1-51-1, Hatsudai Shibuya-ku, Tokyo
TEL
+81-3-6276-3662
Homepage URL
c.tanigawa@suimin.co.jp
Sponsor or person
Institute
TOYO SHINYAKU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
+81-3-6868-7022
jccr-info@cts-smo.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
| 2025 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065045
