Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
NAFLD
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 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.
Interventions
DRUG2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk
DRUGStandard Soy Milk
Consumption of commercially available soy milk
Sponsors
Marialena Mouzaki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Prospective parallel arm randomized controlled study
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver disease severity | 12 weeks | Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials. |
Secondary
| Measure | Time frame |
|---|---|
| Change in gamma glutamyl-transferase levels (GGT) | 12 weeks |
| Change in alkaline phosphatase (ALP) | 12 weeks |
| Change in fasting triglycerides | 12 weeks |
| Change in total cholesterol (TC) | 12 weeks |
| Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels | 12 weeks |
| Change in glucose | 12 weeks |
| Change in insulin | 12 weeks |
| Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP]) | 12 weeks |
| Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels | 12 weeks |
| Change in thyroid function (TSH and Free T4) | 12 weeks |
| Change in estradiol | 12 weeks |
| Change in serum metabolome and lipidome | 12 weeks |
| Change in systolic and diastolic blood pressure | 12 weeks |
| Change in equol production status | 12 weeks |
| Change in glycated hemoglobin (HbA1c) | 12 weeks |
Countries
United States
Contacts
Primary ContactAnn Popelar
Outcome results
None listed