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

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 Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: 2% Fat Cow's Milk; Drug: Standard Soy Milk

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Allison Sullivan; Phone Number: 513-803-1065; Email: allison.sullivan2@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Allison Sullivan; Phone Number: 513-803-1065; Email: allison.sullivan2@cchmc.org
      • Principal Investigator: Marialena Mouzaki, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	Time Frame
Change in insulin	12 weeks
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 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

Collaborators and Investigators

• Sponsor: Marialena Mouzaki

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2023-0416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No