Plants Optimizing Development Study (PODS)

NCT06276426 — Not applicable, Unknown, 96 participants, University of Illinois at Urbana-Champaign

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Plants Optimizing Development Study

Registry	NCT06276426, acronym PODS
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	96 (Estimated)
Sponsor	University of Illinois at Urbana-Champaign (Other); collaborators: Soy Nutrition Institute
Conditions	Healthy Children
Interventions	Soy foods, Non-Soy Plant-Based Foods (Other)
Dates	start 2024-03-18, primary completion 2026-09-30 (estimated), completion 2026-09-30 (estimated), first posted 2024-02-26, last updated 2024-04-17
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Soy	Experimental	Other: Soy foods	The experimental group will be asked to consume 2 servings/day of soy foods for 3 months
Non-Soy Plant-Based Foods	Active comparator	Other: 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 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.

+Outcome measures

Primary outcomes

Sex steroid excretion [3 months (Baseline vs Follow-up)]: urinary concentration of androgen and estrogenic steroids

Secondary outcomes

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.
Attentional Accuracy [3 months (Baseline vs Follow-up)]: Changes in accuracy (%) between groups using a computerized flanker task.
Attentional Reaction Time [3 months (Baseline vs Follow-up]: Changes in reaction time (ms) between groups using a computerized flanker task.
Hippocampal-dependent Relational memory [3 months (Baseline vs Follow-up)]: Spatial memory task accuracy.
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.).
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.
Cognitive Abilities and Academic Achievement [3 months (Baseline vs Follow-up)]: Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement

+Eligibility

Sex: All, ages: 8 Years to 11 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Illinois	Urbana, Illinois	United States	Recruiting