Home › Steatotic Liver Disease › NCT06133101
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Who can join
Ages 5 to 16 · All sexes
Full 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 \<10%
About the study
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.
What is being tested
- Standard Soy Milk (drug)
- 2% Fat Cow's Milk (drug)
Sponsor: Marialena Mouzaki · Participants: 44 · Started: Jan 15, 2024
Contact the study team
- Ann Popelar · Phone: (513) 636-8867
Official record on ClinicalTrials.gov — NCT06133101
Locations in the U.S.
| Ohio | Cincinnati Children's Hospital Medical Center, Cincinnati |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.