Dietary Interventions for Fatty Liver Disease

Overseen By Yvonne Edgerly

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Corewell Health West

Must not be taking: Oral steroids, Amiodarone, TPN

Disqualifiers: Diabetes, Chronic liver disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Miriam B Vos, MD, MSPH

Principal Investigator

Corewell Health West and Michigan State University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 11 and 17 years old.

I have at least one risk factor like high BMI, blood pressure, cholesterol, or signs of prediabetes.

Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI

Exclusion Criteria

Albumin less than 3.2 g/dL

Current participation in another clinical trial

Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Essential Amino Acids Supplementation or Low Sugar Diet intervention

24 weeks

Regular visits at baseline, 12 weeks, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Essential Amino Acids Supplementation intervention
• Low sugar diet

How Is the Trial Designed?

Group I: Essential Amino Acids Supplementation Active Control 1 Intervention

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.

Group II: Low Sugar Diet Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Corewell Health West

Lead Sponsor

Van Andel Research Institute

Collaborator

Trials

28

Recruited

5,200+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

The Amino Company

Collaborator