Trial Parameters
Brief Summary
This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.
Eligibility Criteria
Inclusion Criteria: * Child assent and parent/guardian consent * Free of any food allergy * 8-11 years of age * Tanner scale score of ≤ 2 * 20/20 or corrected vision * No antibiotic usage in the past 3 months * ≤1 serving/d of soy food habitual consumption Exclusion Criteria: * Non-assent or consent by child assent and/or parent/guardian * Presence of any food allergy * Younger than 8 years or older than 11 years * Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome) * Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease * Tanner scale score of \> 2 * Not 20/20 or uncorrected vision * Antibiotic usage in the past 3 months * \>1 serving/d of soy food habitual consumption