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

RECRUITINGPhase 2Sponsored by Marialena Mouzaki
Actively Recruiting
PhasePhase 2
SponsorMarialena Mouzaki
Started2024-01-15
Est. completion2026-03
Eligibility
Age5 Years – 12 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 5 Years – 12 YearsHealthy volunteers accepted
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

Conditions2

Liver DiseaseNon Alcoholic Fatty Liver Disease

Locations1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Ann Popelar513-636-8867Ann.Popelar@cchmc.org

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