Plants Optimizing Development Study (PODS)
ConditionHealthy Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorUniversity of Illinois at Urbana-Champaign
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Child assent and parent/guardian consent
Free of any food allergy
8-11 years of age
Tanner scale score of ≤ 2
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Soy foods
Other interventionSoy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
Non-Soy Plant-Based Foods
Other interventionPea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: SoyExperimental treatment 1 intervention
Group B: Non-Soy Plant-Based FoodsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sex steroid excretion
urinary concentration of androgen and estrogenic steroids
Time frame
3 months (Baseline vs Follow-up)Secondary outcomes
1
Gut microbiota
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.
Time frame
3 months (Baseline vs Follow-up)2
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Time frame
3 months (Baseline vs Follow-up)3
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Time frame
3 months (Baseline vs Follow-up4
Hippocampal-dependent Relational memory
Spatial memory task accuracy.
Time frame
3 months (Baseline vs Follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Urbana-Champaign
Lead sponsor
Soy Nutrition Institute
Collaborator
Source ClinicalTrials.gov