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

Phase 2RecruitingNCT06133101

Marialena Mouzaki44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Standard Soy MilkDRUG

Consumption of commercially available soy milk

2% Fat Cow's MilkDRUG

Consumption of commercially available 2% cow's milk

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children with overweight/obesity * Known NAFLD or elevated ALT (\>30) Exclusion Criteria: * 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 * MRI PDFF \<10%

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])

Time frame: 12 weeks

Change in gamma glutamyl-transferase levels (GGT)

Time frame: 12 weeks

Change in alkaline phosphatase (ALP)

Time frame: 12 weeks

Change in fasting triglycerides

Time frame: 12 weeks

Change in total cholesterol (TC)

Time frame: 12 weeks

Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels

Time frame: 12 weeks

Change in glucose

Time frame: 12 weeks

Change in insulin

Time frame: 12 weeks

Change in glycated hemoglobin (HbA1c)

Time frame: 12 weeks

Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels

Central Contacts

Ann Popelar

CONTACT

(513) 636-8867 Ann.Popelar@cchmc.org

Data from ClinicalTrials.gov

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