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Recruiting NCT06133101

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

Conditions: Non-Alcoholic Fatty Liver Disease

Sex: All
Ages: 5 Years – 16 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 44
Sponsor: Marialena Mouzaki

Location: Cincinnati Children's Hospital Medical Center Cincinnati Ohio

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

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06133101). StuddyBuddy aggregates publicly available trial information.