Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061735) titled 'A safety study of test food intake in healthy adults' on June 10.

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 the test food intake 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 with a BMI of 25 or more and less than 30 (3) 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 diseases such as mental disorders, diabetes, liver diseases, renal diseases, gastrointestinal diseases, cardiac diseases, respiratory diseases, peripheral vascular diseases, or other serious diseases. (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 or drugs. (6) Subjects with symptoms of anemia. (7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or lactating. (8) Subjects who play intense sports or who are on a diet. (9) Subjects with extremely irregular eating habits. (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study 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) Subjects who are judged by the investigator or subinvestigator to be inappropriate for the study. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 06 Month 11 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070650

Disclaimer: Curated by HT Syndication.