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Evaluation of an effect on human intestinal microbiota with taking of okara powder in a randomized double-blind study

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049294
Enrollment
24
Registered
2022-11-01
Start date
2022-10-31
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1.Defecation frequency: more than 2times and less than 5times/week 2. Body mass index(BMI): more than 20 and less than 30

Interventions

Soy protein powder 15g /day Feeding period
4 weeks Okara powder 15g / day Feeding period

Sponsors

Seiichiro Aoe Otsuma Womens University Faculty of Home Economics Department Food Science
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria:

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change of diversity index of bacteria in intestines by DNA analysis to genus in feces. Timing of fecal sampling:0W/ 4W/

Secondary

MeasureTime frame
-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/

Countries

Japan

Contacts

Public ContactYasuyo Ito

Graduate School of Studies, Otsuma Women's University Human Culture Studies

ykishimu@ybb.ne.jp+81-3-5275-6048

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026