Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Recruiting · NCT06133101 · Interventional (participants receive a specific treatment) · Lead sponsor: Marialena Mouzaki
View the official record on ClinicalTrials.gov →Interventions studied
2% Fat Cow's MilkStandard Soy Milk
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.
Who can take part
Age range
5 Years to 12 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States