Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058366) titled 'A study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children,' on April 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Mibyou Life Science Inc.

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

Objective: Narrative objectives1 - The object of this study is to evaluate the effects of a 12-week continuous intake of the test food on cognitive functions related to memory and learning in healthy children who are native Japanese speakers and are third- and fourth-grade elementary school students attending regular classes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 12-week continuous intake of the test food containing lactic acid bacteria Interventions/Control_2 - 12-week continuous intake of the placebo food without lactic acid bacteria

Eligibility: Age-lower limit - 8 years-old = Gender - Male and Female Key inclusion criteria - 1) Subjects who are native Japanese speakers, currently enrolled in regular third- or fourth-grade elementary school classes at the time of consent (born between April 2, 2015 and April 1, 2017). 2) Subjects who are not receiving any medical treatment. 3) Subjects who are able to attend scheduled assessments and complete required records. 4) Subjects who, along with their legally authorized representatives (parents/guardians), have received sufficient explanation about the study and have voluntarily provided written informed consent. Key exclusion criteria - 1) Subjects who have been diagnosed with any neurodevelopmental disorders, intellectual disabilities, or other psychiatric conditions. 2) Subjects who have a history of serious disorders related to glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, digestive system, endocrine system, immune system, or nervous system. 3) Subjects who have visual or auditory impairments or related disorders. 4) Subjects who have allergies to drugs or foods that may affect the study. 5) Subjects who are unable to refrain from consuming specified health foods, including Foods for Specified Health Uses (FOSHU), foods with functional claims, or other dietary supplements during the study period. 6) Subjects who are unable to consume the test food as instructed. 7) Subjects who are currently participating in another clinical trial or investigational study. 8) Subjects who are unable to follow the instructions of the principal investigator or are deemed unsuitable for participation by the principal investigator. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 05 Month 12 Day Date of IRB - 2025 Year 06 Month 04 Day Anticipated trial start date - 2025 Year 07 Month 19 Day Last follow-up date - 2025 Year 12 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066725

Disclaimer: Curated by HT Syndication.