UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060916 |
|---|---|
| Receipt number | R000069232 |
| Scientific Title | A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial-- |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/02/12 11:26:28 |
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Basic information
Public title
A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Acronym
A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements
Scientific Title
A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Scientific Title:Acronym
A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects on bowel movements and safety following 4 weeks of continuous consumption of the food containing fermented rice bran.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bowel movements recorded in the bowel movement diary
Key secondary outcomes
*Secondary Evaluation Items
1) Number of bowel movements days per week, stool volume, stool consistency, stool odor, sensation of incomplete evacuation, sense of relief, pain, straining (as recorded in bowel movement diary)
2) Salivary assays
3) VAS questionnaire regarding quality of life (QOL)
*Safety Assessment
1) Blood Pressure/Pulse
2) Weight/Body Fat Percentage/BMI
3) Physician Consultation/Assessment of Adverse Events and Side Effects
4) Daily Activity Log
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the active food (1 cupsule per day for 4 weeks)
Interventions/Control_2
Intake of the placebo food (1 cupsule per day for 4 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 20 years or older but under 65 years at the time of obtaining consent to participate in the study.
2) Healthy individuals without chronic physical conditions, including skin diseases.
3) Individuals experiencing mild constipation with relatively hard stool consistency.
4) Individuals with spontaneous bowel movements approximately 3 to 5 times per week.
5) Individuals who have received sufficient explanation regarding the purpose and content of this study, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study.
6) Individuals who can attend the designated examination date and undergo the examination.
7) Individuals deemed suitable for participation in this study by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing pharmacological treatment.
2) with a history or current presence of hemorrhoids, chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3) with a history or current condition of serious liver, kidney, heart, lung, blood, brain, or gastrointestinal disorders.
4) diagnosed with irritable bowel syndrome or inflammatory bowel disease.
5) with periodontal disease or needing dental treatment during the study.
6) who have taken or applied medication for disease treatment within the past month.
7) who habitually take laxatives, intestinal regulators, or similar medications.
8) under treatment for functional constipation or similar conditions.
9) diagnosed with chronic constipation under the 2023 Diagnostic Guidelines for Bowel Dysfunction.
10) with severe anemia.
11) with a BMI of 30.0 kg/m2 or higher.
12) with allergies to test food components, other foods, or medications.
13) whose use of bowel-improving foods or supplements has changed or may change during the study.
14) who used functional foods containing rice bran fermented within the past 3 months.
15) with irregular eating habits or a tendency toward an unbalanced diet
16) whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women.
17) with regular exercise habit (>=30 minutes per session, at least twice per week).
18) with smoking habits.
19) who may need allergy medication during the study.
20) with irregular lifestyles, such as shift work or night work.
21) who may alter their lifestyle habits during the study period.
22) who donated 200 mL within 1 month or 400 mL within 3 months before the study.
23) in another clinical study or within 3 months of one.
24) pregnant, breastfeeding, or planning pregnancy during the study.
25) otherwise deemed ineligible for this study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tagawa |
Organization
Maruzen Pharmaceuticals Co., Ltd.
Division name
Research & Development Division
Zip code
729-3102
Address
1089-8, Shinichi-cho Sagata, Fukuyama, Hiroshima
TEL
0847-52-5501
t-tagawa@maruzenpcy.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 15 | 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 | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069232
