Plants Optimizing Development Study (PODS)

Healthy Children Clinical Trial

— PODS  

Official title:

Plants Optimizing Development Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276426
• Other study ID #: 24468
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Naiman Khan, PhD, RD
• Phone: 2173002197
• Email: nakhan2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Children

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Soy Nutrition Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex steroid excretion	urinary concentration of androgen and estrogenic steroids	3 months (Baseline vs Follow-up)
Secondary	Gut microbiota	Gut microbiota will be assessed using a fecal sample. Outcomes will include a-diversity/community richness and evenness (Shannon Index), ß-diversity (microbial structures), and Firmicutes:Bacteroidetes ratio.	3 months (Baseline vs Follow-up)
Secondary	Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	3 months (Baseline vs Follow-up)
Secondary	Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	3 months (Baseline vs Follow-up
Secondary	Hippocampal-dependent Relational memory	Spatial memory task accuracy.	3 months (Baseline vs Follow-up)
Secondary	Body Composition	DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.	3 months (Baseline vs Follow-up)
Secondary	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)
Secondary	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)
Secondary	Cognitive Abilities and Academic Achievement	Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement	3 months (Baseline vs Follow-up)