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

September 18, 2026 updated by: Marialena Mouzaki

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • Marialena Mouzaki, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marialena Mouzaki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

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)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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