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Cancer Vaccine

Soy Milk for Non-alcoholic Fatty Liver Disease

Phase 2
Recruiting
Research Sponsored by Marialena Mouzaki
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

"This trial will compare the effects of drinking soy milk versus cow's milk in children with Non-alcoholic Fatty Liver Disease (NAFLD). Researchers believe that the soy isoflavones in soy

Who is the study for?
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).Check my eligibility
What is being tested?
The study compares the effects of drinking standard soy milk versus 2% fat cow's milk on the severity of NAFLD in children. It aims to see if soy isoflavones in soy milk can help reduce liver disease.See study design
What are the potential side effects?
No adverse endocrine or metabolomic side effects from consuming soy isoflavones are expected according to the investigators' hypothesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in liver disease severity
Secondary outcome measures
Change in alkaline phosphatase (ALP)
Change in equol production status
Change in estradiol
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Soy MilkExperimental Treatment1 Intervention
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Group II: 2% Fat Cows MilkPlacebo Group1 Intervention
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.

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Who is running the clinical trial?

Marialena MouzakiLead Sponsor
~29 spots leftby Mar 2026
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