SMART Diets for MASLD

Conditions

• Metabolic-dysfunction Associated Steatotic Liver Disease

Eligibility Criteria

Sex

ALL

Age

11 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Essential Amino Acids Supplementation intervention — DRUG
  EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine
• Low sugar diet — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Dec 26, 2029

Completion

Dec 26, 2030

Study Design

Enrollment

102 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Essential Amino Acids Supplementation
  The essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase.
• Active Comparator: Low Sugar Diet
  The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. 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.

Primary Outcome Measure

Change in hepatic steatosis [ Time Frame: Baseline to 24 weeks ]

Central Contacts

• Miriam B Vos, MD, MSPH
  616-267-2100
  [email protected]

Locations (1)

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