Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Phase 2
Recruiting
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Registration Number
- NCT06133101
- Lead Sponsor
- Marialena Mouzaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Children with overweight/obesity<br><br> - Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF >10%<br><br> - Known NAFLD or elevated ALT for sex (>22 for females and >26 for males)<br><br>Exclusion Criteria:<br><br> - MRI-PDFF <10%<br><br> - Baseline habitual (>3 days per week) consumption of soy foods<br><br> - Allergy to soy or cow's milk protein<br><br> - Inability to undergo MRI<br><br> - Recent (past 8 weeks) antibiotic exposure<br><br> - Treatment for existing endocrine disorders
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in liver disease severity
- Secondary Outcome Measures
Name Time Method Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP]);Change in gamma glutamyl-transferase levels (GGT);Change in alkaline phosphatase (ALP);Change in fasting triglycerides;Change in total cholesterol (TC);Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels;Change in glucose;Change in insulin;Change in glycated hemoglobin (HbA1c);Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels;Change in thyroid function (TSH and Free T4);Change in estradiol;Change in serum metabolome and lipidome;Change in systolic and diastolic blood pressure;Change in equol production status