Tokyo, May 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061654) titled 'A study to verify the safety of excessive consumption of the test food: an open-label study' on May 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Yotsuba Milk Products Co., Ltd.

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

Objective: Narrative objectives1 - To conduct a safety verification study for excessive consumption of five times the recommended daily intake of Lactococcus cremoris subsp. cremoris YRC3780. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Capsule containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take 10 capsules with water without chewing per day.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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 undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

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 are taking "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 medicines or foods related to the test product

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

8. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 13 Day Date of IRB - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 05 Month 22 Day Last follow-up date - 2026 Year 09 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070543

Disclaimer: Curated by HT Syndication.