Effects of soy milk on liver health in children with fatty liver disease
Official title: Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Run by Children's Hospital Medical Center, Cincinnati · NCT06133101 · Data updated 2026-11-12
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 |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | January 15, 2024 |
| Main results expected | March 2028 |
| Study ends | September 2028 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT06133101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children with overweight or obesity who have been diagnosed with NAFLD and have an MRI PDFF greater than 10%.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with overweight/obesity * Known NAFLD or elevated ALT (\>30) Exclusion Criteria: * 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 * MRI PDFF \<10%
Where it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver
We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.
-
Lowering insulin to reduce liver fat production
This study will try a short course of diazoxide to lower insulin and see if it reduces the liver's creation of new fat in adults with obesity, insulin resistance, and MASLD.
-
Efimosfermin alfa for adults with liver impairment
This trial will test a single dose of efimosfermin alfa in adults with cirrhosis-related hepatic impairment from steatotic liver disease, with and without significant alcohol use, to measure drug levels and safety.
-
Efimosfermin alfa for adults with biopsy-confirmed F2 or F3 MASH
This trial will test whether efimosfermin alfa can resolve steatohepatitis and improve liver-related outcomes in adults with biopsy-confirmed F2 or F3 MASH.
-
Efimosfermin alfa injections for adults with F2–F3 MASH
This study tests whether efimosfermin alfa injections are safe and tolerable for adults (18–75) with known or suspected metabolic dysfunction-associated steatohepatitis (MASH) and F2–F3 fibrosis.
-
Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver
This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.