Tokyo, July 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062110) titled 'Effects of test food consumption on liver function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on July 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - MAINICHIEGAO. CO., LTD.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on liver function in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 4 weeks Test product: Kange Suibonsou 9 tablets (0 placebo tablets) Administration: Consume 9 tablets of Kange Suibonsou per day with water

*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. Interventions/Control_2 - Duration: 4 weeks Test product: Kange Suibonsou 6 tablets (3 placebo tablets) Administration: Consume a total of 9 tablets per day (6 tablets of Kange Suibonsou and 3 placebo tablets) with water

*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 =30 U/L at screening 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

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 - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 10 Day Date of IRB - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2026 Year 11 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071062

Disclaimer: Curated by HT Syndication.