Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Purpose
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.
Condition
- Non-Alcoholic Fatty Liver Disease
Eligibility
- Eligible Ages
- Between 5 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective parallel arm randomized controlled study
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator 2% Fat Cows Milk |
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks. |
|
|
Experimental Standard Soy Milk |
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks. |
|
Recruiting Locations
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
More Details
- Status
- Recruiting
- Sponsor
- Marialena Mouzaki