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SMART Diets for MASLD

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Sponsor changed: Corewell Health West to Michigan State Universityv2 Show 4 more changesShow less
    • Recruitment opened
    • Start date: Apr 26, 2026 to Jun 2026
    • Site details revised
    • Collaborators: 4 to 3
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
Trial Details
NCT Number NCT07459504
Lead Sponsor Michigan State University
Collaborators: Emory University, Corewell Health West, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Metabolic-dysfunction Associated Steatotic Liver Disease
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov