← Back to all trials
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 \
Source: ClinicalTrials.gov (NCT06133101). StuddyBuddy aggregates publicly available trial information.