Plants Optimizing Development Study (PODS)

Conditions

• Healthy Children

Eligibility Criteria

Sex

ALL

Age

8 Years - 11 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 18, 2024

Status verified

Apr 2024

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Soy
  The experimental group will be asked to consume 2 servings/day of soy foods for 3 months
• Active Comparator: Non-Soy Plant-Based Foods
  The control group will be asked to consume 2 servings/day of non-soy plant-based foods for 3 months

Primary Outcome Measure

Sex steroid excretion [ Time Frame: 3 months (Baseline vs Follow-up) ]

Central Contacts

• Naiman Khan, PhD, RD
  2173002197
  [email protected]

Locations (1)

Find similar trials in Urbana, IL

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