Tokyo, July 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062303) titled 'Safety Evaluation of Excessive Intake of a Food Containing Myricetin and Luteolin' on July 27.

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 males and females Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety of excessive intake of a food containing myricetin and luteolin in study subjects. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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 from 20 to 64 years old (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 mental illness, 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 or kidney function tests (4) Subjects with currently treated medical conditions (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Female participants wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female participants (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular lifestyles (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 receiving treatment with pharmaceuticals (including OTC and prescription drugs) (12) Subjects who drink exceed 40 g of average pure daily alcohol (13) Subjects who smoke an average of 21 or more cigarettes a day (14) Subjects who are participating in or will participate in other clinical trials at the start of this study (15) Others, subjects judged by the principal investigator or the co-investigator to be inappropriate for the examination Target Size - 23

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 17 Day Date of IRB - 2026 Year 06 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 28 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071236

Disclaimer: Curated by HT Syndication.