Soy Milk for Non-alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether drinking soy milk can help children with Non-alcoholic Fatty Liver Disease (NAFLD), a liver condition common in those who are overweight. Researchers aim to determine if soy isoflavones (natural compounds in soy) can improve liver health compared to 2% fat cow's milk. Participants will be divided into two groups: one drinking soy milk and the other cow's milk, both twice a day for 12 weeks. This trial suits children who are overweight, have been diagnosed with NAFLD, or have had high liver enzymes, but do not regularly consume soy foods. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are being treated for existing endocrine disorders, you may not be eligible to participate.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that soy milk is generally safe for everyone, including children. Studies have found that soy isoflavones, natural compounds in soy milk, do not harm hormones or metabolism. In fact, consuming soy has been linked to health benefits, such as lowering certain liver enzymes and improving insulin levels. This suggests that soy milk might help improve liver health in conditions like non-alcoholic fatty liver disease (NAFLD). So far, no major reports of negative effects from drinking soy milk have emerged, indicating it is well-tolerated.12345
Why do researchers think this study treatment might be promising for NAFLD?
Researchers are excited about using soy milk for non-alcoholic fatty liver disease (NAFLD) because it offers a natural and potentially lower-risk alternative to existing treatments like lifestyle changes and medications such as vitamin E or pioglitazone. Unlike these standard options, soy milk may target liver health through its unique composition, rich in isoflavones and plant proteins, which might help reduce liver fat and inflammation. This approach could provide a more holistic method of managing NAFLD, appealing to those seeking dietary-based interventions.
What evidence suggests that soy milk might be an effective treatment for NAFLD?
Research has shown that soy milk might help treat Non-alcoholic Fatty Liver Disease (NAFLD). Studies have found that compounds in soy, called isoflavones, can lower liver enzymes like ALT and AST, which indicate liver health. Evidence also suggests that soy can reduce liver fat and improve overall liver function. Additionally, soy might help manage cholesterol levels and improve insulin use, both important for people with NAFLD. In this trial, participants will receive either standard soy milk or 2% fat cow's milk. These findings suggest that soy milk could be a helpful option for children with this condition.12678
Are You a Good Fit for This Trial?
This trial is for children with non-alcoholic fatty liver disease (NAFLD) who are overweight or obese. They must have an MRI PDFF >10% and elevated ALT levels (>22 for females, >26 for males).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume either standard soy milk or 2% fat cow's milk twice daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Soy Milk
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marialena Mouzaki
Lead Sponsor