UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061841 |
|---|---|
| Receipt number | R000070742 |
| Scientific Title | Effects of Plant-Derived ingredients on Sleep [g2026003] |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2026/06/09 11:40:48 |
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Basic information
Public title
Effects of Plant-Derived ingredients on Sleep
Acronym
Effects of Plant-Derived ingredients on Sleep
Scientific Title
Effects of Plant-Derived ingredients on Sleep [g2026003]
Scientific Title:Acronym
Effects of Plant-Derived ingredients on Sleep [g2026003]
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of plant-derived extracts on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean percentage of NREM(Non-Rapid Eye Movement) stage N3 sleep on Wednesday-Friday nights after 2-week intake of the test product containing plant-derived ingredients.
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will take the active test product once daily for 2 consecutive weeks, followed by a 1-week washout period, and then take the placebo test product once daily for 2 consecutive weeks.
Interventions/Control_2
Participants will take the placebo test product once daily for 2 consecutive weeks, followed by a 1-week washout period, and then take the active test product once daily for 2 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Japanese men aged 30-59 years who were born and raised in Japan, and whose cohabiting family members were also born and raised in Japan.
2. Individuals who self-report that their sleep is light/shallow or easily interrupted.
3. Individuals who agree to wear a wearable device (Fitbit).
4. Individuals with an AIS (Athens Insomnia Scale) >= 6 and < 16.
5. Individuals whose weekday (Monday-Friday) wake-up time is 9 am or earlier, from the month immediately prior to enrollment through the study period.
Key exclusion criteria
1. Sleep apnea diagnosed within past 1 year, or suspected based on snoring.
2. BMI >= 35 kg/m^2.
3. Urination >= 3 times/night (nocturia).
4. Difficulty maintaining continuous night sleep due to caregiving/cohabitants and/or living environment.
5. Scheduled major medical intervention during study (e.g., hospitalization, surgery).
6. Severe underlying disease (cardiac, hepatic, or renal).
7. History of psychiatric disorders (e.g., depression, ADHD).
8. Current continuous use, or planned start during study: hypnotics, antidepressants, or anxiolytics.
9. Continuous use within past 1 month (>= 3 times/week), or planned start during study: sleep-related foods with function claims and/or supplements.
10. Allergic reactions to specific foods (e.g., anaphylaxis with respiratory distress).
11. Metal allergy.
12. Prone to skin irritation from alcohol swabs, adhesive gel, or medical tape.
13. Skin conditions at device sites (forehead, behind ear, chest, wrist, instep).
14. Prior similar tests: device wearing caused insomnia or daily-life interference (portable EEG (electroencephalogram), skin temperature logger, wearable).
15. Strong anxiety or fear about wearing/attaching devices.
16. Expected prolonged water activities (except bathing) and/or excessive sweating during study.
17. Night shifts/rotating shifts, or scheduled night shifts during study.
18. Scheduled travel with time zone changes (jet lag) during study.
19. Heavy alcohol consumption.
20. Another study participation at consent, or planned participation during the period.
21. Self or family employed by healthcare-related companies.
22. Deemed inappropriate by PI (principal investigator) (or principal physician/investigator).
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Human Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3297-0978
fukagawa.satoko@kao.com
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Suganuma |
Organization
Human Health Care Products Research Lab.
Division name
Kao Corporation
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3297-0986
Homepage URL
suganuma.takaya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Cross Marketing Group Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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 | 06 | Month | 19 | 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
| 2026 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070742
