Plants Optimizing Development Study (PODS)

Recruiting now · Not applicable

Conditions studied: Healthy Children

In brief

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.

Key facts

Study ID

NCT06276426

Run by

University of Illinois at Urbana-Champaign

People needed

96

Starts

2024-03-18

Expected to finish

2026-09-30

Last updated by the study team

2024-04-17

Who can join

Age: 8 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Illinois — Urbana, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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