Tokyo, Jan. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060469) titled 'A study to evaluate the safety of excessive consumption of the test food' on Jan. 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Macrophi Inc.

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

Objective: Narrative objectives1 - To evaluate the safety of excessive consumption of the test food. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Food containing lipopolysaccharide (LPS) derived from Pantoea agglomerans Administration: Consume 10 capsules per day after the first meal of the day, either by allowing them to dissolve in the mouth or by chewing them. They may also be consumed 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 <= 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 medicines (including herbal medicines) or supplements

6. Individuals who have allergies to medicines or foods related to the test product, particularly those with a silver allergy or concerns about wheat allergy

7. Individuals who are pregnant, lactating, or planning to become pregnant 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 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 01 Month 14 Day Date of IRB - 2026 Year 01 Month 14 Day Anticipated trial start date - 2026 Year 01 Month 26 Day Last follow-up date - 2026 Year 04 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069162

Disclaimer: Curated by HT Syndication.