Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Marialena Mouzaki
44 participants
Jan 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Consumption of commercially available soy milk
Consumption of commercially available 2% cow's milk
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06133101