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NOT YET RECRUITING
NCT07459504
PHASE2

SMART Diets for MASLD

Sponsor: Corewell Health West

View on ClinicalTrials.gov

Summary

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.

Official title: A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth

Key Details

Gender

All

Age Range

11 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-04-26

Completion Date

2030-12-26

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Essential Amino Acids Supplementation intervention

EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine

OTHER

Low sugar diet

The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.

Locations (1)

Corewell Health West

Grand Rapids, Michigan, United States