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.
The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
96
Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.
University of Illinois
Urbana, Illinois, United States
RECRUITINGSex steroid excretion
urinary concentration of androgen and estrogenic steroids
Time frame: 3 months (Baseline vs Follow-up)
Gut microbiota
Gut microbiota will be assessed using a fecal sample. Outcomes will include α-diversity/community richness and evenness (Shannon Index), β-diversity (microbial structures), and Firmicutes:Bacteroidetes ratio.
Time frame: 3 months (Baseline vs Follow-up)
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Time frame: 3 months (Baseline vs Follow-up)
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Time frame: 3 months (Baseline vs Follow-up
Hippocampal-dependent Relational memory
Spatial memory task accuracy.
Time frame: 3 months (Baseline vs Follow-up)
Body Composition
DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.
Time frame: 3 months (Baseline vs Follow-up)
Metabolic Markers
Fasted venous blood will be collected from the antecubital vein of the arm to measure TG, LDL, HDL, TC, and FG using the Piccolo Xpress Analyzer (Abaxis, Inc.).
Time frame: 3 months (Baseline vs Follow-up)
Pubertal Staging
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Tanner pubertal stage will be assessed using the Growing and Changing Questionnaire. The survey consists of line drawings23 representing the Tanner stages for genital size and for pubic hair and to record which drawing most closely represents the child's stage.
Time frame: 3 months (Baseline vs Follow-up)
Cognitive Abilities and Academic Achievement
Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement
Time frame: 3 months (Baseline vs Follow-up)