Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062625) titled 'Investigation of the Effect of Test Food on the Regulation of intestinal function' on Aug. 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

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

Objective: Narrative objectives1 - To investigate the effects of food components in the test food on the regulation of intestinal function in healthy male and female subjects aged 20 to less than 65 years following consumption of the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of the test foods for 4 weeks. Interventions/Control_2 - Continuous intake of the placebo foods for 4 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old 2.Subjects who have a tendency toward constipation with 2 to 5 bowel movements per week. 3.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document. Key exclusion criteria - 1.Subjects diagnosed with constipation. 2.Subjects with diabetes, liver, kidney, digestive, heart, respiratory, peripheral vascular, or metabolic diseases, or a history of severe manifestations. 3.Subjects with mental disorders, sleep disorders, or a history of such conditions. 4.Subjects who had a gastrointestinal surgery. 5.Subjects with abnormal parameters in liver and/or kidney function. 6.Subjects with a disease currently under treatment. 7.Subjects who are at risk of having allergic reactions to drugs or foods. 8.Subjects with anemia. 9.Subjects who regularly consume medicines, supplements, or health foods that support the regulation of intestinal function, or foods rich in components that may influence the regulation of intestinal function, such as lactic acid bacteria, bifidobacteria, oligosaccharides, or dietary fiber. 10.Subjects using antibiotics or other drugs affecting intestinal microbiota, or planning to use them during the study. 11.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 12.Subjects who play high intensity sports and/or are on a diet. 13.Subjects whose eating, sleeping, and other habits are extremely irregular. 14.Subjects unable to discontinue health foods, supplements, or quasi-drugs during the study. 15.Subjects who are under treatment with medications (including OTC and/or prescribed medications). 16.Subjects who consume more than 40 g of alcohol per day. 17.Subjects who smoke 21 or more cigarettes per day. 18.Subjects who participated in another clinical study within 3 months before consent or plan to participate during this study. 19.Subjects who have undergone blood donation (200 mL or more within 1 month, or 400 mL or more within 3 months prior to giving informed consent). 20.Subjects who are pregnant, planning to become pregnant during the study period, or currently breastfeeding. 21.Subjects judged unsuitable for the study by the investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 22 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 09 Month 10 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071688

Disclaimer: Curated by HT Syndication.