Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Standard Soy Milk
* Drug: 2% Fat Cow's Milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective parallel arm randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2% Fat Cows Milk<br>Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks. | Drug: 2% Fat Cow's Milk<br>* Consumption of commercially available 2% cow's milk<br>|
| Experimental: Standard Soy Milk<br>Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks. | Drug: Standard Soy Milk<br>* Consumption of commercially available soy milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver disease severity | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP]) |  | 12 weeks | 
| 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 glycated hemoglobin (HbA1c) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD