Plants Optimizing Development Study (PODS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Soy foods, Non-Soy Plant-Based Foods.
- Who it may be relevant to
- Registry conditions: Healthy Children. Basic parameters: 8 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Plants Optimizing Development Study
Overview
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
- Other Soy foods
Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes. - Other Non-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.
Primary outcome measures
- Sex steroid excretion [Time frame: 3 months (Baseline vs Follow-up)]
Secondary outcome measures (8)
- Gut microbiota [Time frame: 3 months (Baseline vs Follow-up)]
- Attentional Accuracy [Time frame: 3 months (Baseline vs Follow-up)]
- Attentional Reaction Time [Time frame: 3 months (Baseline vs Follow-up]
- Hippocampal-dependent Relational memory [Time frame: 3 months (Baseline vs Follow-up)]
- Body Composition [Time frame: 3 months (Baseline vs Follow-up)]
- Metabolic Markers [Time frame: 3 months (Baseline vs Follow-up)]
- Pubertal Staging [Time frame: 3 months (Baseline vs Follow-up)]
- Cognitive Abilities and Academic Achievement [Time frame: 3 months (Baseline vs Follow-up)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Illinois — Urbana
Identifiers
NCT: NCT06276426 · 24468