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NCT06133101 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by Marialena Mouzaki.

Recruiting
Registry status
Phase 2
Development phase
44
Enrollment target
1
Study location

NCT06133101: Recruiting Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by Marialena Mouzaki.

NCT06133101 is a Phase 2 study of Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by Marialena Mouzaki. The registered enrollment target is 44 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06133101, a Phase 2 study of Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by Marialena Mouzaki.

RECRUITING
Registry status
Phase 2
Development phase
44 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Standard Soy Milk
  • DRUG 2% Fat Cow's Milk

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2024-01-15
Est. Completion 2026-06
Phase Phase 2
Marialena Mouzaki

1 total trials

What NCT06133101 shows while recruiting

NCT06133101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (75% lower).

The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Standard Soy Milk is the first listed.

NCT06133101 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT06133101 about?

NCT06133101 is a clinical study titled "Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)". 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...

What is the current status of trial NCT06133101?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2024-01-15. Estimated completion is 2026-06.

What conditions does trial NCT06133101 study?

This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.

What interventions are being tested in trial NCT06133101?

The interventions under investigation include: Standard Soy Milk (DRUG), 2% Fat Cow's Milk (DRUG).

Who is sponsoring clinical trial NCT06133101?

This trial is sponsored by Marialena Mouzaki, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06133101 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-alcoholic Fatty Liver Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06133101's enrollment target sits among peer trials

44 38th of 57 higher than 20 of 57 other Non-alcoholic Fatty Liver Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06133101, the US trial registry maintained by the National Library of Medicine. NCT06133101 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.