Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059050) titled 'Research on the functional and safety assessment of test food intake' 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 - Miura Clinic, Medical Corporation Kanonkai

Condition: Condition - Healthy elementary school student Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluation of the effects and safety on immune function by continuously ingestion of test food for 8 weeks. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 8 consecutive weeks

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - (1) Healthy elementary school students (1st to 6th grades: excluding menstrual periods) (2) Subjects whose parents or legal guardians (hereinafter referred to as 'guardians') received a full explanation of the purpose and content of the study, fully understood it, and voluntarily provided written informed consent for the subject's participation in the study 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 showing abnormal liver and kidney function test values. (4) Subjects with a current medical condition. (excluding cavity treatment) (5) Subjects who are allergic to food and drugs. (6) Subjects who participate in strenuous sports and subjects who are trying to lose weight. (7) Subjects with extremely irregular eating habits. (8) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period. (9) Subjects who are continuously treated with medications (including OTC, prescription drugs). (10) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study. (11) Other subjects judged by the investigator or the investigator to be inappropriate for the examination. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 28 Day Date of IRB - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 09 Month 18 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=R000067539

Disclaimer: Curated by HT Syndication.