UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061086 |
|---|---|
| Receipt number | R000069896 |
| Scientific Title | Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress. |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 15:40:25 |
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Basic information
Public title
Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress.
Acronym
Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress.
Scientific Title
Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress.
Scientific Title:Acronym
Research on the effects of fermentable dietary fiber intake and behavioral intervention on sleep and stress.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of 4-week combined use of fermentable dietary fiber-containing food and behavioral intervention (meditation) on changes in sleep quality, stress levels, and the intestinal environment among healthy adult men and women aged 20 to 49.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep quality (electroencephalogram and sleep-related questionnaires) at baseline and after 4 weeks of intake.
Key secondary outcomes
The following items at baseline and after 4 weeks of intake.
Various questionnaires regarding stress, defecation status, and skin concerns
Salivary total IgA
Intestinal microbiota
Fecal organic acids (acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, and formic acid)
Cumulative days of cold symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily consumption of one bottle of fermentable dietary fiber-containing food (a total of 24 bottles) over the 4-week intervention period.
Perform meditation once daily before bedtime as much as possible for 4 weeks.
Interventions/Control_2
none
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese aged 20 to 49 years at the time of providing informed consent
3.Persons who have concerns regarding sleep and stress
Key exclusion criteria
1.Persons with chronic illnesses receiving medical treatment or having a serious medical history.
2.Persons diagnosed with sleep disorders by a physician, such as sleep apnea syndrome or insomnia.
3.Persons with a history of or current treatment for psychiatric disorders, such as depression or anxiety disorders.
4.Persons taking psychotropic medications, including hypnotics, anxiolytics, or antidepressants.
5.Persons with severe chronic diseases, such as hypertension, diabetes, liver disease, or kidney disease.
6.Persons likely to develop seasonal allergic symptoms that may significantly affect sleep during the study period.
7.Persons whose sleep is disturbed by painful conditions, such as neuralgia or arthritis.
8.Persons working shifts or frequently traveling abroad with significant time zone changes.
9.Persons with a habit of excessive alcohol consumption.
10.Persons with a habit of excessive caffeine intake.
11.Persons with a smoking habit who may be affected by the arousal effects of nicotine.
12.Persons with a habit of strenuous exercise that may significantly affect sleep due to physical fatigue.
13.Persons who regularly practice meditation or have strict sleep habits that are difficult to modify.
14.Persons regularly using medications or health foods that may affect sleep, stress, or immunity.
15.Persons regularly using medications, health foods, or prebiotic or probiotic products that may affect defecation or the intestinal environment.
16.Persons with allergies to the test food.
17.Persons who habitually and actively consume dietary fiber.
18.Persons who have recently experienced or are likely to experience significant mental stress due to life events.
19.Persons with recent (within 1 month) or planned participation in other research.
20.Persons judged ineligible by the principal investigator.
21.Persons who are pregnant, breastfeeding, or planning pregnancy.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 03 | 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
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069896
