Tokyo, April 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061271) titled 'Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement' on April 15.

Study Type: Interventional

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

Primary Sponsor: Institute - Hiroshima University

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

Objective: Narrative objectives1 - To evaluate the time course of exhaled hydrogen concentration following oral administration of different doses of a silicon-containing supplement Basic objectives2 - Others

Intervention: Interventions/Control_1 - Oral administration of a silicon-containing supplement according to a predefined stepwise algorithm. All participants receive 300 mg at the first administration and 100 mg at the second administration. Based on the increase in exhaled hydrogen concentration after 100 mg, participants proceed to either 50 mg or 200 mg at the third administration. Among participants who receive 50 mg, up to three participants with the highest AUC of the increase in exhaled hydrogen concentration up to 8 hours proceed to 25 mg at the fourth administration. Exhaled hydrogen concentration is measured up to 8 hours after each administration, and selected participants after 300 mg undergo additional measurements at 11 and 24 hours according to a predefined rule. A 1-week washout period is provided between administrations.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Healthy Key exclusion criteria - 1) Individuals currently taking medicines and/or dietary supplements 2) Individuals with food allergies 3) Individuals currently participating in another clinical study, or who have participated in another clinical study within the past 3 months 4) Individuals who are pregnant, may be pregnant, or are breastfeeding 5) Individuals judged by the principal investigator or sub-investigator to be ineligible for participation in this study Target Size - 8

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 04 Month 15 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=R000069604

Disclaimer: Curated by HT Syndication.