UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058168 |
|---|---|
| Receipt number | R000064289 |
| Scientific Title | Single-arm open intervention study on bowel movements using Himeiku No.83 sake lees powder |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/13 09:52:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Single-arm open intervention study on bowel movements using Himeiku No.83 sake lees powder
Acronym
Intervention study on bowel movements using sake lees powder
Scientific Title
Single-arm open intervention study on bowel movements using Himeiku No.83 sake lees powder
Scientific Title:Acronym
Intervention study on bowel movements using sake lees powder
Region
| Japan |
Condition
Condition
Bowel movements
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we conduct a short-term intervention study on healthy subjects after processing sake lees made from Himeiku No. 83 into powder to confirm the effect of sake lees powder, which is high in resistant protein that may contribute to maintaining good bowel movements. We also aim to tabulate the intake methods of sake lees powder, which is characterized by its taste, and to find acceptable ways to consume sake lees powder for future intervention studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movements and defecation (Japanese version of Constipation Assessment Scale, defecation frequency, defecation volume, stool shape and odor, and items related to defecation in the Gastrointestinal Symptom Rating Scale)
Key secondary outcomes
Consume method of sake lees powder, subjective awakening and skin glow.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1 package of 3g sake lees powder per meal, 3 packages per day. The intervention period is 7 days.
Interventions/Control_2
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy persons who do not meet the exclusion criteria
Key exclusion criteria
1. Those who currently have chronic intestinal diseases and are attending the hospital regularly (constipation, diarrhea, intestinal cancer, inflammatory bowel disease, irritable bowel syndrome, etc.)
2. Those who have a history of intestinal resection (excluding polypectomy)
3. Those who have been visiting the hospital regularly and have not obtained approval from the doctor
4. Those who are allergic to rice or sake lees
5. Other subjects who are judged to be inappropriate by the study investigator or the physician in charge of the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
maruyama.kotatsu.rt@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5040
rinri@m.ehime-u.ac.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
| 2025 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064289
