Actively Recruiting
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Led by Marialena Mouzaki · Updated on 2024-08-20
44
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with overweight or obesity
- Diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) and MRI PDFF greater than 10%
- Known NAFLD or elevated ALT levels above 22 for females and above 26 for males
You will not qualify if you...
- MRI PDFF less than 10%
- Habitual consumption of soy foods more than 3 days per week
- Allergy to soy or cow's milk protein
- Unable to undergo MRI
- Antibiotic use within the past 8 weeks
- Treatment for existing endocrine disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
A
Ann Popelar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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