SMART Diets for MASLD

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.

Conditions

• Metabolic-dysfunction Associated Steatotic Liver Disease

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.

Sponsors & Collaborators

• Van Andel Research Institute

  collaborator OTHER

• Emory University

  collaborator OTHER

• Michigan State University

  collaborator OTHER

• The Amino Company

  collaborator UNKNOWN

• Corewell Health West

  lead OTHER

Principal Investigators

• Miriam B Vos, MD, MSPH · Corewell Health West and Michigan State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-26

Primary Completion

2029-12-26

Completion

2030-12-26

FDA Drug

Yes

Countries

• United States

Study Locations