RECRUITING

Plants Optimizing Development Study (PODS)

Conditions

Healthy Children soy isoflavones cognition body composition fecal microbiota metabolic risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Plants Optimizing Development Study

Quick Facts

Study Start:2024-03-18

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06276426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Naiman Khan, PhD, RD

CONTACT

2173002197

nakhan2@illinois.edu

Study Locations (Sites)

University of Illinois

Urbana, Illinois, 61801

United States

Collaborators and Investigators

Sponsor: University of Illinois at Urbana-Champaign

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

Study Start Date2024-03-18

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-03-18

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

soy
isoflavones
cognition
body composition
fecal microbiota
metabolic risk

Additional Relevant MeSH Terms

Healthy Children