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.
Children with overweight/obesity
Known NAFLD or elevated ALT (>30)
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
Parallel
Standard Soy Milk
DrugConsumption of commercially available soy milk
2% Fat Cow's Milk
DrugConsumption of commercially available 2% cow's milk
Change in liver disease severity
Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.
Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])
Change in gamma glutamyl-transferase levels (GGT)
Change in alkaline phosphatase (ALP)
Change in fasting triglycerides
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Marialena Mouzaki
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Sponsor institution
