UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058888 |
|---|---|
| Receipt number | R000067307 |
| Scientific Title | Verification study of the effects of foods containing plant extracts on sleep |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/25 15:37:54 |
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Basic information
Public title
Verification study of the effects of foods containing plant extracts on sleep
Acronym
Verification study of the effects of foods containing plant extracts on sleep
Scientific Title
Verification study of the effects of foods containing plant extracts on sleep
Scientific Title:Acronym
Verification study of the effects of foods containing plant extracts on sleep
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of foods containing plant extracts on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue scale (VAS)for fatigue upon waking
Key secondary outcomes
MA version of the OSA sleep questionnaire upon waking, Visual analogue scale (VAS) for sleep quality upon waking, Visual analogue scale (VAS) for fatigue upon going to bed, Chalder questionnaire, abbreviated version of POMS2 questionnaire, BMI (calculated from height and weight), blood pressure, pulse, sleep record, daily diary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take foods containing plant extract once a day for 14 days
Interventions/Control_2
Take placebo once a day for 14 days
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 and Female
Key inclusion criteria
1. Healthy male and female aged 30-59
2. Person who work day shifts, 5 days a week with weekends off
3. Person who commute by train and whose main occupation is in an industry other than primary industry or manual labor
4. Person who are dissatisfied or worried about their sleep
5. Person who feel tired when they wake up (3 or more days a week on weekdays) and whose fatigue improves on Saturdays and Sundays.
Key exclusion criteria
1.Person with a history of serious diseases such as circulatory, cardiovascular, digestive, endocrine diseases, mental illness, or malignant neoplasms.
2.Person with a BMI of 25 or greater, or 18 or less. If participant numbers are low, those with a BMI of 27 or greater, or 18 or less may be accepted.
3.Person with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
4.Person consuming more than 40g of alcohol (about 2 go of sake) daily.
5.Person who smoke cigarettes regularly or occasionally.
6.Person diagnosed with chronic fatigue syndrome.
7.Person who sleep less than 5 hours or more than 7 hours on average on weekdays.
8.Person regularly taking medications that affect sleep or fatigue.
9.Person with significant variations in sleep duration, wake-up, and bedtime.
10.Person planning major life changes (e.g.,higher education, job changes, moving) during the study period.
11.Person experiencing symptoms that affect sleep.
12.Person living with preschool children (under 3 years old) or those needing nighttime care.
13.Pregnant Person, those wishing to become pregnant, or breastfeeding during the study.
14.Person unable to properly evaluate using a Visual Analogue Scale.
15.Person who have difficulty understanding or filling out the questionnaire in Japanese.
16.Person allergic to any ingredients in the test product (excluding 28 specified allergens).
17.Person unable to consume ingredients with unspecified origins due to religious or other reasons.
18.Person already involved in other research or those planning to participate in additional studies during the trial period, or those who have participated in other drug or food trials within the past month.
19.Person deemed inappropriate for participation by the principal investigator.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Umeda |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
umeda.mai@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
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
| 2025 | Year | 08 | Month | 27 | 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 | 08 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067307
