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

Recruiting now · Phase 2

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT06133101

Run by

Marialena Mouzaki

People needed

44

Starts

2024-01-15

Expected to finish

2026-06-01

Last updated by the study team

2024-08-20

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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