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

RECRUITING

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.

I'm interested

ALL
5 years to 12 years old
This study is NOT accepting healthy volunteers

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

DRUG: Standard Soy Milk, DRUG: 2% Fat Cow's Milk

Non-Alcoholic Fatty Liver Disease

NAFLD

Ann Popelar - Ann.Popelar@cchmc.org
PHASE2
NCT06133101
See this study on ClinicalTrials.gov

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