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

Description

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Overview

Study Details

Study 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.

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

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

Condition
Non-Alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

5 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Marialena Mouzaki,

Study Record Dates

2026-06