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Recruiting NCT06133101

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

Phase II Interventional Non-Alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Soy Milk, 2% Fat Cow's Milk.
Who it may be relevant to
Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Drug Standard Soy Milk
    Consumption of commercially available soy milk
  • Drug 2% Fat Cow's Milk
    Consumption of commercially available 2% cow's milk

Primary outcome measures

  • Change in liver disease severity [Time frame: 12 weeks]
Secondary outcome measures (12)
  • 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 [Time frame: 12 weeks]
  • Change in thyroid function (TSH and Free T4) [Time frame: 12 weeks]
  • Change in estradiol [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cincinnati Children's Hospital Medical Center — Cincinnati

Identifiers

NCT: NCT06133101 · 2023-0416

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗