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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 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 189-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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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

Sponsor

Marialena Mouzaki

1 total trials

What the Registry Record Tells You About NCT06133101

The ClinicalTrials.gov registry entry for NCT06133101 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (77% lower). The listed sponsor is Marialena Mouzaki, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.