Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062982) titled 'A verification study to evaluate the safety of excessive consumption of the test food: an open-label study' on Sept. 18.

Study Type: Interventional

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

Primary Sponsor: Institute - ICHIBIKI CO., LTD.

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

Objective: Narrative objectives1 - To verify the safety of consuming the test food at five times the regular daily intake for four weeks. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Tablet containing Zygosaccharomyces rouxii KURAHANA YZK-1 Administration: Open the test food package along the perforated line and take three tablets with water. Take the tablets at the same time each day as much as possible.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medications or foods related to the test product (particularly wheat or soy)

7. Individuals who are pregnant, lactating, or planning pregnancy during this study

8. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 09 Month 09 Day Date of IRB - 2026 Year 09 Month 09 Day Anticipated trial start date - 2026 Year 09 Month 18 Day Last follow-up date - 2026 Year 12 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072109

Disclaimer: Curated by HT Syndication.