Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 5 to 16

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.

More Non-Alcoholic Fatty Liver Disease trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages5 Years to 16 Years
SexAll
Enrollment44 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedJanuary 15, 2024
Main results expectedMarch 2028
Study endsSeptember 2028
Registry record updatedSeptember 22, 2026
Trial IDNCT06133101 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.