RECRUITING Phase 2 ClinicalTrials.gov

Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Sponsor: Marialena Mouzaki • ClinicalTrials.gov ID: NCT06133101

Registry updated: 2026-09-22

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Description

A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.

Interventions

Standard Soy Milk (Drug)
Consumption of commercially available soy milk
2% Fat Cow's Milk (Drug)
Consumption of commercially available 2% cow's milk

Eligibility 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%

Conditions

Non-Alcoholic Fatty Liver Disease

Locations

Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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