NCT06133101 Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
| NCT ID | NCT06133101 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Marialena Mouzaki |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2024-01-15 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06133101 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06133101 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06133101 currently recruiting?
Yes, NCT06133101 is actively recruiting participants. Contact the research team at Ann.Popelar@cchmc.org for enrollment information.
Where is the NCT06133101 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06133101 clinical trial?
NCT06133101 is sponsored by Marialena Mouzaki. The trial plans to enroll 44 participants.