Plants Optimizing Development Study (PODS) (PODS)

Plants Optimizing Development Study

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Children
• Intervention / Treatment: Other: Soy foods; Other: Non-Soy Plant-Based Foods

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naiman Khan, PhD, RD; Phone Number: 2173002197; Email: nakhan2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois
      • Contact: Naiman Khan, PhD, RD; Phone Number: 217-300-2197; Email: nakhan2@illinois.edu
      • Principal Investigator: Naiman Khan, PhD, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soy; The experimental group will be asked to consume 2 servings/day of soy foods for 3 months	Other: Soy foods; Soy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex steroid excretion	urinary concentration of androgen and estrogenic steroids	3 months (Baseline vs Follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	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.	3 months (Baseline vs Follow-up)
Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	3 months (Baseline vs Follow-up)
Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	3 months (Baseline vs Follow-up
Hippocampal-dependent Relational memory	Spatial memory task accuracy.	3 months (Baseline vs Follow-up)
Body Composition	DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.	3 months (Baseline vs Follow-up)
Metabolic Markers	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.).	3 months (Baseline vs Follow-up)
Pubertal Staging	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.	3 months (Baseline vs Follow-up)
Cognitive Abilities and Academic Achievement	Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement	3 months (Baseline vs Follow-up)

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Soy Nutrition Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cognition; body composition; metabolic risk; isoflavones; soy; fecal microbiota
• Other Study ID Numbers: 24468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No