Plants Optimizing Development Study (PODS)

NCT ID: NCT06276426

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Healthy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Soy

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

Group Type EXPERIMENTAL

Soy foods

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Non-Soy Plant-Based Foods

Intervention Type OTHER

Pea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.

Interventions

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Soy foods

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soy Nutrition Institute

UNKNOWN

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Illinois

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Naiman Khan, PhD, RD

Role: CONTACT

2173002197

Facility Contacts

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Naiman Khan, PhD, RD

Role: primary

217-300-2197

Other Identifiers

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24468

Identifier Type: -

Identifier Source: org_study_id

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