Plants Optimizing Development Study (PODS)
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.
Conditions:
🦠 Healthy Children
🗓️ Study Start (Actual) 18 March 2024
🗓️ Primary Completion (Estimated) 30 September 2026
✅ Study Completion (Estimated) 30 September 2026
👥 Enrollment (Estimated) 96
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Urbana, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 8 Years to 11 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 February 2024
  • First Submitted that Met QC Criteria 16 February 2024
  • First Posted 26 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 17 April 2024
  • Last Verified April 2024