Actively Recruiting

Phase Not Applicable
Age: 8Years - 11Years
All Genders
Healthy Volunteers
NCT06276426

Plants Optimizing Development Study (PODS)

Led by University of Illinois at Urbana-Champaign · Updated on 2024-04-17

96

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Urbana-Champaign

Lead Sponsor

S

Soy Nutrition Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Plants Optimizing Development Study (PODS)

Who Can Participate

Age: 8Years - 11Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child assent and parent or guardian consent
  • Free of any food allergy
  • 8 to 11 years of age
  • Tanner scale score of 64 2
  • 20/20 or corrected vision
  • No antibiotic usage in the past 3 months
  • Habitual consumption of 641 serving per day of soy food
Not Eligible

You will not qualify if you...

  • Lack of assent or consent by child or parent/guardian
  • Presence of any food allergy
  • Younger than 8 years or older than 11 years
  • Specific neurological or genetic disorders such as Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome
  • Endocrine, metabolic, or gastrointestinal diseases like hypertension, diabetes, or celiac disease
  • Tanner scale score greater than 2
  • Not 20/20 or uncorrected vision
  • Antibiotic usage in the past 3 months
  • Habitual consumption of more than 1 serving per day of soy food

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois

Urbana, Illinois, United States, 61801

Actively Recruiting

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Research Team

N

Naiman Khan, PhD, RD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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