RECRUITINGPhase 2INTERVENTIONAL
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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
Treatments Being Tested
DRUG
Standard Soy Milk
Consumption of commercially available soy milk
DRUG
2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States