University of Illinois
Urbana, Illinois, 61801, United States
Location status: Recruiting
Location contact
Naiman Khan, PhD, RD
CONTACT
Naiman Khan, PhD, RD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06276426
Plants Optimizing Development Study (PODS)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
8 year–11 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Soy foods
OtherSoy milk, soy yogurt, tofu, tempeh, soy nuts, edamame, soy protein bar, and soy-based frozen meat substitutes.
Non-Soy Plant-Based Foods
OtherPea milk, almond milk yogurt, chickpeas, chickpea chips, lentil chips, non-soy protein bar, and non-soy based frozen meat substitutes.
Primary outcomes
-
Sex steroid excretion
Time frame: 3 months (Baseline vs Follow-up)
urinary concentration of androgen and estrogenic steroids
Secondary outcomes
-
Gut microbiota
Time frame: 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
Time frame: 3 months (Baseline vs Follow-up)
Changes in accuracy (%) between groups using a computerized flanker task.
-
Attentional Reaction Time
Time frame: 3 months (Baseline vs Follow-up
Changes in reaction time (ms) between groups using a computerized flanker task.
-
Hippocampal-dependent Relational memory
Time frame: 3 months (Baseline vs Follow-up)
Spatial memory task accuracy.
-
Body Composition
Time frame: 3 months (Baseline vs Follow-up)
DXA scans will be used to assess whole body bone density and Android:Gynoid ratio.
-
Metabolic Markers
Time frame: 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
Time frame: 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
Time frame: 3 months (Baseline vs Follow-up)
Woodcock Johnson Tests of Cognitive Abilities and Academic Achievement
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Illinois at Urbana-Champaign
Other
Collaborators
- Soy Nutrition Institute
Registry information
Official study title
Plants Optimizing Development Study
Acronym: PODS
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 26, 2024
- Registry last updated
- Apr 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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