Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059001) titled 'Food monitor survey on whole Jinenjo Dango for improving the gut environment' on Sept. 12.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - M-TEX Corporation

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

Objective: Narrative objectives1 - To assess the improvement of the gut environment after 8 weeks of consuming processed foods made with whole Jinenjo. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 8 weeks

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Subjects aged 18 to 65 as of April 1, 2025 2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent 3. Subjects who have not taken any foods for specified health uses, functional foods, dietary supplements, that may affect defecation, or who can maintain the same type and frequency of intake of these products they have been taking up until that point during the study period Key exclusion criteria - 1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery 3.Subjects with an allergy to the test food 4.Subjects who are suffering from or have a history of a disease that may affect defecation 5.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator 6.Subjects who have used antibiotics within the past month 7.Subjects who have had the habit of drinking vinegar (including fruit vinegar, black vinegar, etc.) continuously within the past 3 months 7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period 8.Subjects with smoking habits 9.Subjects with high alcohol consumption (60g or more of pure alcohol per day) 10.Subjects with a frequency of fewer than three bowel movements per week 11.Subjects with irregular lifestyles due to night shifts 12.Female subjects who are pregnant or lactating, or intending to become pregnant during the study 13.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 14.Subjects deemed unsuitable by the investigator Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 14 Day Date of IRB - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 09 Month 12 Day Last follow-up date - 2025 Year 12 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067477

Disclaimer: Curated by HT Syndication.