NCT06133101RecruitingPhase 2
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 15 Jan 2024
- Primary completion date
- Mar 2028
- Lead sponsor
- Marialena Mouzaki
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06133101
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 15 Jan 2024 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to soy or cow's milk protein
- Treatment for existing endocrine disorders
Other
- Baseline habitual (\>3 days per week) consumption of soy foods
- Inability to undergo MRI
- Recent (past 8 weeks) antibiotic exposure
- MRI PDFF \<10%
Who the study is looking for
- Children with overweight/obesity
- Known NAFLD or elevated ALT (\>30)
Age in the registry: 5 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.