SMART Diets for MASLD

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.

NCT Number	NCT07459504
Lead Sponsor	Michigan State University Collaborators: Emory University, Corewell Health West, National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Metabolic-dysfunction Associated Steatotic Liver Disease
Enrollment	102 participants
Start Date	2026-06
Primary Completion	2029-12-26 (estimated)
Study Completion	2030-12-26 (estimated)
Updated on ClinicalTrials.gov	2026-06-01