Clinical Trial: Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students (Japan)

Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060297) titled 'Evaluation of an effect on intestinal microbiota with taking of barley and mixed grain rice in a randomized double-blind study in female students' on Jan. 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Seiichiro Aoe Otsuma Women's University Faculty of Home Economics Department of Food Science

Condition: Condition - 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 Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To estimate the effect on the intestinal microbiota and these metabolites by taking barley and mixed grain rice Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Mixed grain rice group: Eat two packs of mixed grain rice per day. Intake for 4 weeks Interventions/Control_2 - Barley and mixed grain rice group: Consume two packs of barley and mixed grain rice per day. Intake for 4 weeks

Eligibility: Age-lower limit - 19 years-old = Gender - Female Key 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 Key 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. Target Size - 52

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 10 Month 01 Day Date of IRB - 2025 Year 07 Month 30 Day Anticipated trial start date - 2025 Year 11 Month 30 Day Last follow-up date - 2026 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068370

Disclaimer: Curated by HT Syndication.