Plants Optimizing Development Study (PODS)
Purpose
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.
Condition
- Healthy Children
Eligibility
- Eligible Ages
- Between 8 Years and 11 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Soy |
The experimental group will be asked to consume 2 servings/day of soy foods for 3 months |
|
|
Active Comparator Non-Soy Plant-Based Foods |
The control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months |
|
Recruiting Locations
University of Illinois
Urbana, Illinois 61801
Urbana, Illinois 61801
More Details
- NCT ID
- NCT06276426
- Status
- Recruiting
- Sponsor
- University of Illinois at Urbana-Champaign
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.