Plants Optimizing Development Study (PODS)
NCT06276426 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2024-04-17
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.
Conditions
- Healthy Children
Interventions
- 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.
Sponsors & Collaborators
-
Soy Nutrition Institute
collaborator UNKNOWN -
University of Illinois at Urbana-Champaign
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-18
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- United States
Study Locations
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