Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059174) titled 'Safety overdose study of test food' on Sept. 24.

Study Type: Interventional

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

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

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

Objective: Narrative objectives1 - To evaluate the safety of overdose of foods containing functional ingredients at five times the normal dose Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Ingestion of test food for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Subjects of men and women aged 20 to 64 (2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing. Key exclusion criteria - (1) Subjects with a history of serious disease such as mental disorder, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (2) Subjects who have undergone gastrointestinal surgery(3) Subjects with abnormal liver and renal function test values (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular eating habits s (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (12) Subjects who drink more than 60 g of pure alcohol per day (13) Subjects who smoke more than 21 cigarettes per day on average (14) Subjects who are participating in or will participate in other clinical trials at the start of this study (15) Other subjects judged by the investigator or the investigator to be inappropriate for the examination Target Size - 17

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 12 Day Date of IRB - 2025 Year 09 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 25 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067680

Disclaimer: Curated by HT Syndication.