Plants Optimizing Development Study (PODS)

University of Illinois at Urbana-Champaign96 enrolled

Overview

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.

The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy Children

Interventions

Soy foodsOTHER

Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.

Non-Soy Plant-Based FoodsOTHER

Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Illinois

Urbana, Illinois, United States

RECRUITING