Actively Recruiting
Plants Optimizing Development Study
Led by University of Illinois at Urbana-Champaign · Updated on 2024-04-17
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Illinois at Urbana-Champaign
Lead Sponsor
S
Soy Nutrition Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to study the effects of daily mixed-soy food consumption compared to non-soy plant-based foods in healthy children aged 8 to 11 years. The study aims to understand how soy isoflavone intake affects sex steroid hormone levels, body composition, metabolic health, gut microbiota, and cognitive functions during pre- and early adolescence. It also investigates changes in soy food acceptance immediately after the trial. Participants are randomly assigned to one of two groups: one group consumes two servings per day of soy foods such as soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bars, and soy-based meat substitutes for three months. The other group consumes two servings per day of non-soy plant-based foods like pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bars, and non-soy meat substitutes over the same period. During the study, researchers assess various health and developmental measures at baseline and after three months, including sex steroid hormone excretion, gut microbiota composition, attentional accuracy and reaction time, relational memory dependent on the hippocampus, body composition, metabolic markers, pubertal development staging, cognitive abilities, and academic achievement. Participants will also be monitored for adherence and any changes in soy food intake acceptance following the intervention period.
CONDITIONS
Brief Title
Plants Optimizing Development Study (PODS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child assent and parent or guardian consent
- No food allergies
- Between 8 and 11 years of age
- Tanner scale score of 2 or less
- Vision of 20/20 or corrected to 20/20
- No antibiotic use in the past 3 months
- Habitual consumption of soy foods is 1 serving per day or less
You will not qualify if you...
- No child assent or parent or guardian consent
- Presence of any food allergy
- Younger than 8 years or older than 11 years
- Diagnosis of neurological or genetic disorders such as Autism, Cerebral Palsy, Multiple Sclerosis, or Down syndrome
- Diagnosis of endocrine, metabolic, or gastrointestinal diseases like hypertension, diabetes, or celiac disease
- Tanner scale score greater than 2
- Vision worse than 20/20 and not corrected
- Antibiotic use in the past 3 months
- Habitual consumption of soy foods more than 1 serving per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants consume either soy foods or non-soy plant-based foods daily as assigned to study the effects on body composition, metabolic health, and cognitive outcomes.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Illinois
Urbana, Illinois, United States, 61801
Actively Recruiting
Research Team
N
Naiman Khan, PhD, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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