Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062803) titled 'A study on the effects of continuous intake of test food on cold-like symptoms in infants and school children' on Sept. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Macromill Carenet, Inc.

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

Objective: Narrative objectives1 - To investigate the effects of 12-week continuous intake of the test food on cold-like symptoms in infants and school children through a randomized, double-blind, placebo-controlled, parallel-group study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of the test food for 12 weeks Interventions/Control_2 - Continuous intake of the placebo food for 12 weeks

Eligibility: Age-lower limit - 3 years-old

Gender - Male and Female Key inclusion criteria - (1) Male or female subjects aged 3 to 12 years old at the time of obtaining consent. (2) Children enrolled in and attending school, kindergarten, or nursery school. (3) Parents (or legal guardians) who can reliably bring the subject to all scheduled visits and accurately complete daily diaries and questionnaires. (4) Parents or legal guardians who have received sufficient explanation regarding the purpose and content of the study, fully understand it, voluntarily apply for the subject's participation, and provide written or electronic informed consent. In addition, subjects who receive an explanation appropriate for their age and level of understanding, and give written, verbal, or electronic informed assent. Key exclusion criteria - (1) Subjects with chronic diseases (such as bronchial asthma or atopic dermatitis) undergoing medical treatment or medication. (2) Subjects who regularly use intestinal regulators or laxatives. (3) Subjects with a history of serious cerebrovascular, cardiac, hepatic, renal, hematologic, metabolic, endocrine, or respiratory diseases. (4) Subjects with immune dysfunction or taking immunosuppressive drugs (e.g., cyclosporine, methotrexate, azathioprine). (5) Subjects diagnosed with developmental disorders (autism spectrum disorder, ADHD, etc.). (6) Subjects with significant abnormalities in vital signs or physical examination at screening. (7) Subjects with food or drug allergies. (8) Subjects with a history of epilepsy or seizures with loss of consciousness and currently under medical treatment or medication. (9) Subjects with a history of anaphylactic shock. (10) Subjects who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health supplements and cannot refrain from taking them during the study. (11) Subjects with extremely irregular sleep habits or dietary habits. (12) Subjects whose living environment (relocation, change of school/nursery, change in family composition) or dietary/exercise habits may change significantly during the study. (13) Subjects currently participating in other clinical studies, or who participated within 4 weeks prior to screening, or plan to participate during this study. (14) Subjects deemed ineligible by the principal investigator. Target Size - 240

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 03 Day Date of IRB - 2026 Year 09 Month 03 Day Anticipated trial start date - 2026 Year 10 Month 24 Day Last follow-up date - 2027 Year 03 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071738

Disclaimer: Curated by HT Syndication.