Effects of soy milk on liver health in children with fatty liver disease
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
This study is testing if drinking soy milk every day can help improve liver health in children with fatty liver disease compared to regular cow's milk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06133101 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of daily soy milk consumption compared to 2% fat cow's milk on the severity of Non-alcoholic Fatty Liver Disease (NAFLD) in children. It is a randomized, controlled trial that aims to determine if soy isoflavones can help reduce NAFLD and related obesity issues. The study will monitor liver health through MRI assessments and evaluate potential benefits without expecting adverse effects from soy consumption.
Who should consider this trial
Good fit: Ideal candidates are children with overweight or obesity who have been diagnosed with NAFLD and have an MRI PDFF greater than 10%.
Not a fit: Patients who do not have NAFLD or have a baseline soy consumption of more than three days per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that improves liver health in children with NAFLD.
How similar studies have performed: While there is limited data on the specific effects of soy milk in this context, other studies have explored dietary interventions for NAFLD with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with overweight/obesity * Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF \>10% * Known NAFLD or elevated ALT for sex (\>22 for females and \>26 for males) Exclusion Criteria: * MRI-PDFF \<10% * Baseline habitual (\>3 days per week) consumption of soy foods * Allergy to soy or cow's milk protein * Inability to undergo MRI * Recent (past 8 weeks) antibiotic exposure * Treatment for existing endocrine disorders
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Ann Popelar
- Email: Ann.Popelar@cchmc.org
- Phone: (513) 636-8867
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.