Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063356) titled 'A verification study to evaluate the safety of excessive consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Oct. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - NIHON PHARMACEUTICAL CO.,LTD.

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

Objective: Narrative objectives1 - To verify the safety of excessive consumption of the test food in healthy Japanese. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: 4 weeks Test product: Anserine-N Administration: Consume 15 tablets per day at any time during the day. *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: Placebo tablet Administration: Consume 15 tablets per day at any time during the day. *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

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

8. Individuals who have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

9. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 10 Month 07 Day Date of IRB - 2026 Year 10 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 20 Day Last follow-up date - 2027 Year 01 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072519

Disclaimer: Curated by HT Syndication.