Soymilk for Children with Non-alcoholic Fatty Liver Disease (NAFLD)
This study is looking at how drinking standard soy milk might affect children with Non-alcoholic Fatty Liver Disease (NAFLD), a condition where too much fat builds up in the liver. Researchers want to see if the natural compounds in soy milk, called soy isoflavones, can help reduce NAFLD. You could be eligible if you are between 5 and 12 years old, are overweight or have obesity, and have NAFLD confirmed by an MRI scan showing over 10% fat in your liver, or elevated liver enzymes (ALT). The study will compare children who drink standard soy milk to those who drink 2% fat cow's milk. The main goal is to see if there's a change in how severe liver disease is after 12 weeks. The current recruitment status is unclear, but 44 children are planned to enroll.
- Study design
- This is a randomized, controlled study comparing standard soy milk to 2% fat cow's milk. It plans to enroll 44 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 12 weeks, indicating follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
At a glance
Conditions
NCT06133101
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in liver disease severity12 weeks
Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.