NCT06276426

Plants Optimizing Development Study (PODS)

Plants Optimizing Development Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Children

Interventions

Type	Name	Description
OTHER	Soy foods	Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
OTHER	Non-Soy Plant-Based Foods	Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.

Timeline

• Start date: 2024-03-18
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-02-26
• Last updated: 2024-04-17

Locations

1 site across 1 country: United States