Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Marialena Mouzaki
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
- Age range
- 5–12 years
- Sex
- All
- Healthy volunteers
- No
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
- DrugStandard Soy Milk
Consumption of commercially available soy milk
- Drug2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk
Location
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio