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
• Interventions: Drug: 2% Fat Cow's Milk; Drug: Standard Soy Milk

• Registration Number: NCT06133101
• Lead Sponsor: Marialena Mouzaki

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-15
• Study Start: 2024-01-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% Fat Cows Milk	2% Fat Cow's Milk	Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
Standard Soy Milk	Standard Soy Milk	Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	12 weeks
Change in fasting triglycerides	12 weeks
Change in gamma glutamyl-transferase levels (GGT)	12 weeks
Change in total cholesterol (TC)	12 weeks
Change in insulin	12 weeks
Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels	12 weeks
Change in alkaline phosphatase (ALP)	12 weeks
Change in serum metabolome and lipidome	12 weeks
Change in equol production status	12 weeks
Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])	12 weeks
Change in glucose	12 weeks
Change in glycated hemoglobin (HbA1c)	12 weeks
Change in thyroid function (TSH and Free T4)	12 weeks
Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels	12 weeks
Change in estradiol	12 weeks

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States