Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059105) titled 'Overdose safety test' on Sept. 17.

Study Type: Interventional

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

Primary Sponsor: Institute - APO PLUS STATION CO., LTD.

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

Objective: Narrative objectives1 - Evaluate the safety of the test food when consumed at three times the recommended daily intake for 4 weeks. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Daily intake of the test food for 4 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - [1] Healthy males and females in the age more than 20 and less than 70 years. [2] Participants who can submit the written informed consent form. Key exclusion criteria - [1] Participants who are currently undergoing treatment for a serious illness. [2] Participants who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction. [3] Participants with food allergies or those who may be allergic to the test food. [4] Participants who regularly use licensed drugs, quasi-drugs or Chinese herbal medicine that may affect the study and are unable to discontinue their use during the study period. [5] Participants who regularly use health foods that may affect the study and who are unable to discontinue their intake during the study period. [6] Participants who have donated blood or undergone blood collection exceeding 200 mL within one month, or 400 mL within three months, prior to the screening (Week 0) examination date. [7] Participants who may be unable to maintain their daily lifestyle. [8] Participants who are pregnant or breastfeeding or planning to become pregnant during the study period. [9] Participants who participated in other clinical trials within 3 months prior to the date of consent, or plan to participate in other clinical trials during the study period. [10] Participants who are judged as ineligible for the study by the investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 04 Day Date of IRB - 2025 Year 09 Month 11 Day Anticipated trial start date - 2025 Year 09 Month 18 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067612

Disclaimer: Curated by HT Syndication.