Plants Optimizing Development Study (PODS)

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Healthy Children

Treatments: Other: Soy foods; Other: Non-Soy Plant-Based Foods

Study type: Interventional

Funder types: Other

Identifiers

NCT06276426

24468

Details and patient eligibility

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.

Full description

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Soy

Experimental group

Description:

The experimental group will be asked to consume 2 servings/day of soy foods for 3 months

Treatment:

Other: Soy foods

Non-Soy Plant-Based Foods

Active Comparator group

Description:

The control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months

Treatment:

Other: Non-Soy Plant-Based Foods