Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students

Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students - Effects of barley and mixed grain rice intake on intestinal flora and metabolites in female students

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060297

Enrollment

Registered

2026-01-08

Start date

2025-11-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

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

Interventions

Mixed grain rice group: Eat two packs of mixed grain rice per day. Intake for 4 weeks Barley and mixed grain rice group: Consume two packs of barley and mixed grain rice per day. Intake for 4 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
-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/	—

Measure

Time frame

-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/

—

Countries

Japan

Contacts

Public ContactSeiichiro Aoe

Otsuma Women's University Faculty of Home Economics, Department of Food Science

s-aoe@otsuma.ac.jp+81-3-5275-6048

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026