Evaluation of an effect on human intestinal microbiota with taking of okara powder in a randomized double-blind study
- Conditions
- 1.Defecation frequency: more than 2times and less than 5times/week 2. Body mass index(BMI): more than 20 and less than 30
- Registration Number
- JPRN-UMIN000049294
- Lead Sponsor
- Seiichiro Aoe Otsuma Womens University Faculty of Home Economics Department Food Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 24
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of diversity index of bacteria in intestines by DNA analysis to genus in feces. Timing of fecal sampling:0W/ 4W/
- Secondary Outcome Measures
Name Time Method -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/