Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Standard Soy Milk for Non-Alcoholic Fatty Liver Disease

A randomly assigned, 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.

Official registry: https://clinicaltrials.gov/study/NCT06133101 · Marialena Mouzaki · enrollment listed as 44

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Standard Soy Milk, or 2% Fat Cow's Milk. The registry lists allocation as randomized. A randomly assigned, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD).

They plan to enroll about 44 people at Cincinnati. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions: Standard Soy Milk, 2% Fat Cow's Milk

Primary outcome (registry wording): Change in liver disease severity

Who it is for (from inclusion criteria)

  • Ages 5 Years to 16 Years
  • Children with overweight/obesity
  • Known NAFLD or elevated ALT (\>30)

Public study contact (from the registry)

Ann Popelar

(513) 636-8867

Ann.Popelar@cchmc.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06133101 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06133101?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06133101?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary