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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Mar 2026 → Mar 2028
See other at-risk trials from Marialena Mouzaki

Record History

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  1. Primary completion pushed from Mar 2026 to Mar 2028 Show 5 more changesShow less
    • Trial status changed: Unknown → Recruiting
    • Study completion pushed from Jun 2026 to Sep 2028
    • Interventions: 2% Fat Cow's Milk (Drug), Standard Soy Milk (Drug) to 2% Fat Cow's Milk (Drug), Standard Soy Milk (Drug)
    • Eligibility criteria shortened, about 9 words
    • Site details revised
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknown
    • Site contact updated
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2023 to Jan 15, 2024
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06133101
Lead Sponsor Marialena Mouzaki
Conditions
(from sponsor)		 Non-Alcoholic Fatty Liver Disease
Related terms Non-alcoholic Fatty Liver Disease
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov