UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060297 |
|---|---|
| Receipt number | R000068370 |
| Scientific Title | Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 14:09:42 |
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Basic information
Public title
Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students
Acronym
Effects of barley and mixed grain rice intake on intestinal flora and metabolites in female students
Scientific Title
Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students
Scientific Title:Acronym
Effects of barley and mixed grain rice intake on intestinal flora and metabolites in female students
Region
| Japan |
Condition
Condition
1) Subjects with a bowel movement frequency of 2-4 times per week
2) Subjects with a BMI of 18.5 or greater and less than 30
3) Subjects who are able to consume the test food (mixed grain rice) for four weeks during the study period
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect on the intestinal microbiota and these metabolites by taking barley and mixed grain rice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of diversity index of bacteria in intestines by DNA analysis to genus in feces.
Timing of fecal sampling:0W/ 4W/
Key secondary outcomes
-Concentration of Short Chain Fatty Acid and organic acid in feces: Formic acid, acetic acid, propionic acid, iso-butylate, butyric acid, valeric acid, iso valeric acid, lactic acid, succinic acid and
toxic substances in feces (indole, skatole, p-cresol, etc.).
Records of stool frequency before and after barley and mixed grain rice intake
# of fecal sampling: 1 fecal sample/ period
Timing of fecal sampling: 0W/ 4W/
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Mixed grain rice group: Eat two packs of mixed grain rice per day.
Intake for 4 weeks
Interventions/Control_2
Barley and mixed grain rice group: Consume two packs of barley and mixed grain rice per day.
Intake 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
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Subjects with a bowel movement frequency of 2-4 times per week
2) Subjects with a BMI of 18.5 or greater and less than 30
3) Subjects who are able to consume the test food (mixed grain rice) for four weeks during the study period
Key exclusion criteria
1) Subjects with a current or past history of cardiovascular disease, liver disease, kidney disease, digestive disease, respiratory disease, or diabetes.
2) Subjects with a history of malignant disease or those undergoing treatment for a chronic disease.
3) Subjects currently undergoing medication.
4) Subjects with a history of drug or food allergies.
5) Subjects currently taking dietary fiber supplements (dietary fiber-containing products prepared from seaweed, konjac, psyllium, etc.) or whole grains (including whole wheat, brown rice, rye, barley, etc.).
6) Subjects with smoking habits.
7) Subjects who have participated in or are currently participating in other human clinical trials within the past month.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Seiiciro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357,Japan
TEL
+81-3-5275-6048
s-aoe@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357,Japan
TEL
+81-3-5275-6048
Homepage URL
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Seiichiro Aoe
Otsuma Women's University
Faculty of Home Economics
Department of Food Science
Institute
Department
Personal name
Seiichiro Aoe
Funding Source
Organization
Council of Japan Barley Foods Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hakubaku Co., Ltd.
Name of secondary funder(s)
Institute of Human Culture Studies, Otsuma Women's University (Grant Number K2501).
IRB Contact (For public release)
Organization
Otsuma Women's UniversityLife Science Research Ethics Committee
Address
12-Sanban-cho, Chiyoda-ku, Tokyo 102-8357 Japan
Tel
+81-3-5275-6048
s-aoe@otsuma.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
大妻女子大学(東京都）/ Otsuma Women's University(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 08 | 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
52
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068370
