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
Qualifiers
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
Treatments tested in this trial
- Soy foods
- Non-Soy Plant-Based Foods
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Illinois at Urbana-Champaign
Lead sponsor
Soy Nutrition Institute
Collaborator
Source ClinicalTrials.gov