NCT06133101PHASE2Recruiting

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

Marialena Mouzaki

Start Date

1/15/2024

Completion Date

6/1/2026

Summary

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.

Eligibility Criteria

Age Range: 5 years to 12 years

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

Interventions

DRUG

Standard Soy Milk

DRUG

2% Fat Cow's Milk

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Conditions

Non-Alcoholic Fatty Liver Disease

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States