Plants Optimizing Development Study (PODS)

Not Applicable

Recruiting

• Conditions: Healthy Children
• Interventions: Other: Non-Soy Plant-Based Foods; Other: Soy foods

• Registration Number: NCT06276426
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

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.

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-26
• Study Start: 2024-03-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Soy Plant-Based Foods	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
Soy	Soy foods	The experimental group will be asked to consume 2 servings/day of soy foods for 3 months

Primary Outcome Measures

Name	Time	Method
Sex steroid excretion	3 months (Baseline vs Follow-up)	urinary concentration of androgen and estrogenic steroids

Secondary Outcome Measures

Name	Time	Method
Hippocampal-dependent Relational memory	3 months (Baseline vs Follow-up)	Spatial memory task accuracy.
Pubertal Staging	3 months (Baseline vs Follow-up)	Tanner pubertal stage will be assessed using the Growing and Changing Questionnaire. The survey consists of line drawings23 representing the Tanner stages for genital size and for pubic hair and to record which drawing most closely represents the child's stage.
Attentional Reaction Time	3 months (Baseline vs Follow-up	Changes in reaction time (ms) between groups using a computerized flanker task.
Cognitive Abilities and Academic Achievement	3 months (Baseline vs Follow-up)	Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement
Gut microbiota	3 months (Baseline vs Follow-up)	Gut microbiota will be assessed using a fecal sample. Outcomes will include α-diversity/community richness and evenness (Shannon Index), β-diversity (microbial structures), and Firmicutes:Bacteroidetes ratio.
Body Composition	3 months (Baseline vs Follow-up)	DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.
Metabolic Markers	3 months (Baseline vs Follow-up)	Fasted venous blood will be collected from the antecubital vein of the arm to measure TG, LDL, HDL, TC, and FG using the Piccolo Xpress Analyzer (Abaxis, Inc.).
Attentional Accuracy	3 months (Baseline vs Follow-up)	Changes in accuracy (%) between groups using a computerized flanker task.

Trial Locations

Locations (1)

University of Illinois; 🇺🇸 Urbana, Illinois, United States