Study of Daily Soy Food Effects on Hormones, Body, and Brain in Healthy Children Ages 8 to 11

What this Trial Is About

Researchers are conducting a randomized clinical trial to study the effects of daily mixed-soy food consumption compared to non-soy plant-based foods in healthy children aged 8 to 11 years. The study aims to understand how soy isoflavone intake affects sex steroid hormone levels, body composition, metabolic health, gut microbiota, and cognitive functions during pre- and early adolescence. It also investigates changes in soy food acceptance immediately after the trial. Participants are randomly assigned to one of two groups one group consumes two servings per day of soy foods such as soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bars, and soy-based meat substitutes for three months. The other group consumes two servings per day of non-soy plant-based foods like pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bars, and non-soy meat substitutes over the same period. During the study, researchers assess various health and developmental measures at baseline and after three months, including sex steroid hormone excretion, gut microbiota composition, attentional accuracy and reaction time, relational memory dependent on the hippocampus, body composition, metabolic markers, pubertal development staging, cognitive abilities, and academic achievement. Participants will also be monitored for adherence and any changes in soy food intake acceptance following the intervention period.

Plants Optimizing Development Study (PODS)