Status:
RECRUITING
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Marialena Mouzaki
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06133101
Start Date
January 15 2024
End Date
June 1 2026
Last Update
August 20 2024
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229