Clinical Trial: A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial-- (Japan)

Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060916) titled 'A Study on the Effects of Consuming Foods Containing Fermented Rice Bran on Bowel Movements --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--' on March 13.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

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

Objective: Narrative objectives1 - This study aims to evaluate the effects on bowel movements and safety following 4 weeks of continuous consumption of the food containing fermented rice bran. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of the active food (1 cupsule per day for 4 weeks) Interventions/Control_2 - Intake of the placebo food (1 cupsule per day for 4 weeks)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy men and women aged 20 years or older but under 65 years at the time of obtaining consent to participate in the study. 2) Healthy individuals without chronic physical conditions, including skin diseases. 3) Individuals experiencing mild constipation with relatively hard stool consistency. 4) Individuals with spontaneous bowel movements approximately 3 to 5 times per week. 5) Individuals who have received sufficient explanation regarding the purpose and content of this study, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study. 6) Individuals who can attend the designated examination date and undergo the examination. 7) Individuals deemed suitable for participation in this study by the principal investigator. Key exclusion criteria - Individuals 1) currently suffering from any disease and undergoing pharmacological treatment. 2) with a history or current presence of hemorrhoids, chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases. 3) with a history or current condition of serious liver, kidney, heart, lung, blood, brain, or gastrointestinal disorders. 4) diagnosed with irritable bowel syndrome or inflammatory bowel disease. 5) with periodontal disease or needing dental treatment during the study. 6) who have taken or applied medication for disease treatment within the past month. 7) who habitually take laxatives, intestinal regulators, or similar medications. 8) under treatment for functional constipation or similar conditions. 9) diagnosed with chronic constipation under the 2023 Diagnostic Guidelines for Bowel Dysfunction. 10) with severe anemia. 11) with a BMI of 30.0 kg/m2 or higher. 12) with allergies to test food components, other foods, or medications. 13) whose use of bowel-improving foods or supplements has changed or may change during the study. 14) who used functional foods containing rice bran fermented within the past 3 months. 15) with irregular eating habits or a tendency toward an unbalanced diet 16) whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women. 17) with regular exercise habit (>=30 minutes per session, at least twice per week). 18) with smoking habits. 19) who may need allergy medication during the study. 20) with irregular lifestyles, such as shift work or night work. 21) who may alter their lifestyle habits during the study period. 22) who donated 200 mL within 1 month or 400 mL within 3 months before the study. 23) in another clinical study or within 3 months of one. 24) pregnant, breastfeeding, or planning pregnancy during the study. 25) otherwise deemed ineligible for this study by the principal investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 28 Day Date of IRB - 2026 Year 01 Month 29 Day Anticipated trial start date - 2026 Year 03 Month 14 Day Last follow-up date - 2026 Year 04 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069232

Disclaimer: Curated by HT Syndication.