Plants Optimizing Development Study (PODS)

RECRUITING

I'm interested ...!!

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) 2024-03-18

Primary Completion (Estimated) 2026-09-30

Study Completion (Estimated) 2026-09-30

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 Submitted2024-02-16
First Submitted that Met QC Criteria2024-02-16
First Posted2024-02-26

Study Record Updates

Last Update Submitted that Met QC Criteria2024-04-16
Last Update Posted2024-04-17
Last Verified2024-04