Healthy subjects
Conditions
Interventions
12-week continuous intake of the test food containing lactic acid bacteria
12-week continuous intake of the placebo food without lactic acid bacteria
Sponsors
Mibyou Life Science Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Executive function related to learning and memory, assessed by Digit Span, Go/No-Go task, and Stroop test | — |
Secondary
| Measure | Time frame |
|---|---|
| Autonomic nervous system activity (SDNN, LF, HF, LF/HF), Strengths and Difficulties Questionnaire (SDQ; parent-reported), Gut microbiota composition (T-RFLP analysis) | — |
Countries
Japan
Contacts
Public ContactSoichi Yoneda
Mibyou Life Science Inc. Clinical Trial Division
Outcome results
None listed