Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT06133101
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
44 participants
INTERVENTIONAL
2024-01-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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2% Fat Cows Milk
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk
Standard Soy Milk
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Standard Soy Milk
Consumption of commercially available soy milk
Interventions
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Standard Soy Milk
Consumption of commercially available soy milk
2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
12 Years
ALL
No
Sponsors
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Marialena Mouzaki
OTHER
Responsible Party
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Marialena Mouzaki
Professor, Division of Gastroenterology, Hepatology and Nutrition
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-0416
Identifier Type: -
Identifier Source: org_study_id
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