Plants Optimizing Development Study (PODS)

NCT06276426 | Recruiting

• 1 other identifier: 24468
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

soy; isoflavones; cognition; body composition; fecal microbiota; metabolic risk

Outcome Measures

Primary Outcomes (1)

• Sex steroid excretion

  urinary concentration of androgen and estrogenic steroids

  3 months (Baseline vs Follow-up)

Secondary Outcomes (8)

• Gut microbiota

  3 months (Baseline vs Follow-up)

• Attentional Accuracy

  3 months (Baseline vs Follow-up)

• Attentional Reaction Time

  3 months (Baseline vs Follow-up

• Hippocampal-dependent Relational memory

  3 months (Baseline vs Follow-up)

• Body Composition

  3 months (Baseline vs Follow-up)

Study Arms (2)

Soy

EXPERIMENTAL

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

Other: Soy foods

Non-Soy Plant-Based Foods

ACTIVE COMPARATOR

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

Other: Non-Soy Plant-Based Foods

Interventions

Soy foods OTHER

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

Soy

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.

Non-Soy Plant-Based Foods

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child assent and parent/guardian consent
• Free of any food allergy
• years of age
• Tanner scale score of ≤ 2
• /20 or corrected vision
• No antibiotic usage in the past 3 months
• ≤1 serving/d of soy food habitual consumption

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Soy Nutrition Institute: collaborator

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Interventions

Soy Foods

Intervention Hierarchy (Ancestors)

Fermented Foods; Diet, Food, and Nutrition; Physiological Phenomena; Vegetable Products; Vegetables; Food; Food and Beverages

Central Study Contacts

Naiman Khan, PhD, RD

CONTACT

2173002197; nakhan2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (1)