Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062642) titled 'A safety study: an open-label study' on Aug. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - Raffinee International Inc.

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

Objective: Narrative objectives1 - To verify the safety of the test food. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: The test food

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 milk, shrimp, crab, cashew nuts, sesame, soybeans, peach, pork, yam, apple, kiwi, gelatin, salmon, orange, or bananas

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

9. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day

10. Individuals who take dairy products such as milk and cheese at least four times a week

11. Individuals who are restricting their diet or exercising for the purpose of dieting Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 08 Month 05 Day Date of IRB - 2026 Year 08 Month 05 Day Anticipated trial start date - 2026 Year 08 Month 21 Day Last follow-up date - 2026 Year 11 Month 21 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071699

Disclaimer: Curated by HT Syndication.