Plants Optimizing Development Study (PODS)
Plants Optimizing Development Study
University of Illinois at Urbana-Champaign
96 participants
Mar 18, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Child assent and parent/guardian consent
- Free of any food allergy
- years of age
- Tanner scale score of ≤ 2
- /20 or corrected vision
- No antibiotic usage in the past 3 months
- ≤1 serving/d of soy food habitual consumption
Exclusion Criteria9
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06276426