Effects of soy foods on children's health and cognition
Plants Optimizing Development Study
This study is testing whether eating soy foods every day for three months can improve health and thinking skills in children aged 8-11 without affecting their hormone levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 8 Years to 11 Years |
| Sex | All |
| Sponsor | University of Illinois at Urbana-Champaign Academic / other |
| Locations | 1 site (Urbana, Illinois) |
| Trial ID | NCT06276426 on ClinicalTrials.gov |
What this trial studies
This study conducts a randomized clinical trial to evaluate the impact of a 3-month daily mixed-soy food intervention compared to a control group receiving isocaloric foods. It focuses on measuring changes in reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognitive function in children aged 8-11 years. The study also aims to assess the acceptance of soy foods in children following the intervention. The central hypothesis is that increased soy isoflavone consumption will lead to beneficial outcomes without altering sex steroid levels.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 8-11 years who have minimal prior soy food consumption and no food allergies.
Not a fit: Children with specific neurological or genetic disorders, or those with existing metabolic or gastrointestinal diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance children's metabolic health and cognitive function through dietary interventions.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated potential benefits of soy isoflavones in health, suggesting a promising avenue for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Urbana, Illinois
- University of Illinois — Urbana, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Naiman Khan, PhD, RD
- Email: nakhan2@illinois.edu
- Phone: 2173002197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.