Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059138) titled 'Evaluation of the effects of test food intake on improving the gut environment' on Sept. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - Metagen, Inc.

Condition: Condition - Healthy male/female adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to exploratorily evaluate the effects of ingesting the test food for 4 weeks on the gut environment. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Group A: Consume 10 test foods per day Interventions/Control_2 - Group B: Consume 2 test foods per day

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Male and female subjects, aged 20 to 64 years inclusive, at the time of informed consent. (2) Subjects with a bowel movement frequency of 3 to 5 times per week. (3) Subjects who have received a full explanation of the study, are capable of understanding the procedures, and have voluntarily provided written informed consent. Key exclusion criteria - (1) Unable to comply with study dietary restrictions as specified in the "Prohibited/Restricted Food List". (2) Current, recent (within 4 weeks), or planned participation in another clinical trial. (3) Highly irregular lifestyle (e.g., night or rotating shifts). (4) Extremely irregular dietary habits. (5) Excessive alcohol consumption. (6) Current smoker or smoking within the past year. (7) Cohabiting with another study participant. (8) Anticipating significant life changes (e.g., moving, job transfer) during the study. (9) Use of medications affecting study outcomes (e.g., antibiotics, probiotics) within 1 month prior to or during the study. (10) Receiving continuous oral medication for a medical condition. (11) History of surgery potentially affecting study outcomes within 6 months prior to consent. (12) History of appendectomy. (13) History or current diagnosis of a severe cardiac, hepatic, renal, or digestive disease. (14) Pregnant, lactating, or planning pregnancy during the study. (15) Known allergies to drugs or foods. (16) Donation of blood components or 200 mL whole blood within 1 month prior. (17) Male with 400 mL whole blood donation within 3 months prior. (18) Female with 400 mL whole blood donation within 4 months prior. (19) Males whose 12-month total blood draw (including this study) would exceed 1200 mL. (20) Females whose 12-month total blood draw (including this study) would exceed 800 mL. (21) Deemed unsuitable for participation by the investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 23 Day Date of IRB - 2025 Year 07 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 22 Day Last follow-up date - 2025 Year 10 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067370

Disclaimer: Curated by HT Syndication.