UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049294 |
|---|---|
| Receipt number | R000056145 |
| Scientific Title | Evaluation of an effect on human microbiota with taking okara powder in a randomized double-blind study |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2025/11/16 18:27:27 |
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Basic information
Public title
Evaluation of an effect on human intestinal microbiota with taking of okara powder in a randomized double-blind study
Acronym
Effect of okara powder on human intestinal microbiota.
Scientific Title
Evaluation of an effect on human microbiota with taking okara powder in a randomized double-blind study
Scientific Title:Acronym
Effect of okara powder on human intestinal microbiota.
Region
| Japan |
Condition
Condition
1.Defecation frequency: more than 2times and less than 5times/week
2. Body mass index(BMI): more than 20 and less than 30
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect on the intestinal microbiota by taking okara powder.
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, isobutylate, butyric acid, valeric acid, iso valeric acid, lactic acid, succinic acid.
-Changes in the Salivary markers
-Estimation of stress feeling by Visual analog scale
-Records of stool frequency before and after okara powder 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
Soy protein powder 15g /day
Feeding period; 4 weeks
Interventions/Control_2
Okara powder 15g / day
Feeding period; 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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese women aged between 20 and 59 years at the time of informed consent
2) Subjects who have 2 to 4 stool frequency per week
3) Subjects with a BMI of 23 or more and less than 30
4) Those who can measure their weight every day and enter it in their diary.
5) Subjects who can take the test food (Okara powder) for 4 weeks .
Key exclusion criteria
1) Subjects with current or history of cardiovascular disease, liver disease, kidney disease, digestive disease, respiratory disease, or diabetes
2) Those who have a history of malignant disease or are undergoing treatment for chronic disease
3) Subjects who are currently undergoing drug treatment
4) Subjects with a history of drug or food allergies
5) Subjects who continuously take dietary fiber supplements (dietary fiber containing products prepared from seaweed, konnyaku, psyllium, etc.) and whole grains (including whole wheat, brown rice, rye, barley, etc.)
6) Currently pregnant, breastfeeding, or possibly pregnant
7) Those who have a smoking habit
8) Those who have participated in other human clinical trials within the past month or are currently participating in other human clinical trials
9) Those who are undergoing treatment for drug dependence/abuse
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Fuculty 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.c.jp
Public contact
Name of contact person
| 1st name | Yasuyo |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Studies, Otsuma Women's University
Division name
Human Culture Studies
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL
+81-3-5275-6048
Homepage URL
ykishimu@ybb.ne.jp
Sponsor or person
Institute
Seiichiro Aoe
Otsuma Womens University
Faculty of Home Economics
Department Food Science
Institute
Department
Personal name
Funding Source
Organization
Japan dried okara association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee for Life Science Studies in Otsuma Women's University
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
Tel
+81-3-5275-6021
bunsho@ml.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
| 2022 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.4327/jsnfs.78.237
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.4327/jsnfs.78.237
Number of participants that the trial has enrolled
24
Results
The results showed a decrease in the Firmicutes/Bacteroidetes ratio (F/B ratio), a significant increase in the relative abundance of Bacteroides and Barnesiella genera, and a significant increase in the alpha diversity index after okara powder consumption.
Results date posted
| 2025 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 22 | Day |
Baseline Characteristics
A randomized, placebo-controlled, double-blind trial was conducted on 24 healthy Japanese women aged 20-50 years, with the approval of the Otsuma Women's University Ethics Committee (Approval Number 04-012). The inclusion criteria were Japanese women aged 20 to 59 years, with 1 to 5 bowel movements per week, a BMI (Body Mass Index) of 18.5 or higher and less than 30, who owned a scale at home and could measure their weight daily and record it in a diary, and who were able to consume the test food during the 4-week trial period. Exclusion criteria included individuals with current or past history of cardiovascular disease, liver disease, kidney disease, gastrointestinal disease, respiratory disease, or diabetes; those with a history of malignant disease or who were receiving treatment for a chronic disease; those receiving medication; those with a history of drug or food allergies; those who were continuously consuming dietary fiber supplements or whole grains; and those who were pregnant, breastfeeding, or potentially pregnant. 24 subjects participated and were randomly assigned to either the okara powder intake group (hereinafter referred to as the okara group) or the placebo group, with 12 subjects in each group.
Participant flow
From 172 applicants, individuals meeting the criteria were randomly selected and divided into two groups, starting with 24 participants. During the study period, one participant dropped out, and after the study ended, two participants were excluded from the analysis because their bowel movement frequency met the exclusion criteria (those who had more bowel movements than the specified number at the start of the study). Therefore, a total of three participants were excluded from the analysis, resulting in 10 participants in the okara group and 11 in the placebo group for the final analysis. At the start of the study, there were no significant differences between the two groups in age, height, weight, BMI, or bowel movement frequency. Dietary intake, as assessed using the FFQ, also showed no significant differences between the two groups or between the pre- and post-study periods.
Adverse events
No adverse events were observed as a result of consuming the test food.
Outcome measures
The primary outcome measure was changes in the gut microbiota, and the secondary outcome measure was changes in the concentration of short-chain fatty acids in the stool.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056145
