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

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marialena Mouzaki

Criteria

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