Tokyo, June 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061984) titled 'Study on the effect of continuous ingestion of a material for 1-deoxy-D-mannose on the host microbiome (gut and vaginal) and urinary excretion dynamics' on June 24.

Study Type: Interventional

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

Primary Sponsor: Institute - Nakamura Gakuen University

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

Objective: Narrative objectives1 - To clarify the long-term effects and efficacy of 1-deoxy-D-mannose (DM) on the human body by conducting a continuous ingestion experiment of DM, and evaluating changes in the host microbiome (gut and verginal), and urinary DM excretion before and after ingestion. Basic objectives2 - Bio-availability

Intervention: Interventions/Control_1 - Duration: 29 days (1 day of pre-ingestion evaluation + 27 days of continuous ingestion + 1 day of post-ingestion evaluation) Test materials: 1-deoxy-D-mannose Dose: 1.0 g Administration: Take once a day. On the 1st day (before continuous ingestion) and the 29th day (after continuous ingestion), the test material is ingested for evaluation, and 24-hour urine is collected. In addition, self-collection of feces and vaginal secretions is performed between 2 days before and the day of each evaluation test. During the 27 days in between, it is continuously ingested once a day.

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key inclusion criteria - Healthy Japanese female adults Key exclusion criteria - The exclusion criteria are a history of diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease, abnormal bowel movements, food allergies, urinary tract infection, or cystitis. Those with a BMI of 25.0 or higher. Those who routinely consume non-digestible and absorbable saccharides such as dietary fiber, or pharmaceuticals (e.g., antibiotics). Those with extreme menstrual irregularity. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 18 Day Date of IRB - 2026 Year 06 Month 18 Day Anticipated trial start date - 2026 Year 06 Month 24 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070928

Disclaimer: Curated by HT Syndication.