Unique ID issued by UMIN | UMIN000049294 |
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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 | 2022/10/24 22:40:57 |
Evaluation of an effect on human intestinal microbiota with taking of okara powder in a randomized double-blind study
Effect of okara powder on human intestinal microbiota.
Evaluation of an effect on human microbiota with taking okara powder in a randomized double-blind study
Effect of okara powder on human intestinal microbiota.
Japan |
1.Defecation frequency: more than 2times and less than 5times/week
2. Body mass index(BMI): more than 20 and less than 30
Adult |
Others
NO
To estimate the effect on the intestinal microbiota by taking okara powder.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Change of diversity index of bacteria in intestines by DNA analysis to genus in feces.
Timing of fecal sampling:0W/ 4W/
-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/
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Soy protein powder 15g /day
Feeding period; 4 weeks
Okara powder 15g / day
Feeding period; 4 weeks
20 | years-old | <= |
59 | years-old | >= |
Female
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 .
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
24
1st name | Seiichiro |
Middle name | |
Last name | Aoe |
Otsuma Women's University
Fuculty of Home Economics, Department of Food Science
102-8357
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
+81-3-5275-6048
s-aoe@otsuma.c.jp
1st name | Yasuyo |
Middle name | |
Last name | Ito |
Graduate School of Studies, Otsuma Women's University
Human Culture Studies
102-8357
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
+81-3-5275-6048
ykishimu@ybb.ne.jp
Seiichiro Aoe
Otsuma Womens University
Faculty of Home Economics
Department Food Science
Japan dried okara association
Non profit foundation
Japan
The Ethics Committee for Life Science Studies in Otsuma Women's University
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
+81-3-5275-6021
bunsho@ml.otsuma.ac.jp
NO
大妻女子大学(東京都)/Otsuma Women’s university (Tokyo)
2022 | Year | 11 | Month | 01 | Day |
Unpublished
Preinitiation
2022 | Year | 10 | Month | 13 | Day |
2022 | Year | 07 | Month | 28 | Day |
2022 | Year | 10 | Month | 31 | Day |
2022 | Year | 12 | Month | 15 | Day |
2023 | Year | 02 | Month | 20 | Day |
2023 | Year | 03 | Month | 20 | Day |
2023 | Year | 04 | Month | 30 | Day |
2022 | Year | 10 | Month | 23 | Day |
2022 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056145
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