Healthy Children
Conditions
Keywords
soy, isoflavones, cognition, body composition, fecal microbiota, metabolic risk
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.
Detailed description
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.
Interventions
OTHERSoy foods
Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
OTHERNon-Soy Plant-Based Foods
Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.
Sponsors
Soy Nutrition Institute
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sex steroid excretion | 3 months (Baseline vs Follow-up) | urinary concentration of androgen and estrogenic steroids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hippocampal-dependent Relational memory | 3 months (Baseline vs Follow-up) | Spatial memory task accuracy. |
| Gut microbiota | 3 months (Baseline vs Follow-up) | 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. |
| Attentional Accuracy | 3 months (Baseline vs Follow-up) | Changes in accuracy (%) between groups using a computerized flanker task. |
| Attentional Reaction Time | 3 months (Baseline vs Follow-up | Changes in reaction time (ms) between groups using a computerized flanker task. |
| Metabolic Markers | 3 months (Baseline vs Follow-up) | 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.). |
| Pubertal Staging | 3 months (Baseline vs Follow-up) | 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. |
| Cognitive Abilities and Academic Achievement | 3 months (Baseline vs Follow-up) | Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement |
| Body Composition | 3 months (Baseline vs Follow-up) | DXA scans will be used to assess whole body bone density and Android:Gynoid ratio. |
Countries
United States
Contacts
Primary ContactNaiman Khan, PhD, RD
Outcome results
None listed