Recruiting
Phase 2

EAA & Low Sugar Diet

Sponsor:

Michigan State University

Code:

NCT07459504

Conditions

Metabolic-dysfunction Associated Steatotic Liver Disease

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Essential Amino Acids Supplementation intervention

Low sugar diet

Study Details

Brief 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

Study ID

NCT07459504

Start date

Jun, 2026

Status verified date

May, 2026

Completion date

Dec 26, 2030

Anticipated

Primary completion date

Dec 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children 11 to 17-years-old at the time of consenting
  • Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
  • At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age/sex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130/80 and/or signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU/mL in prepubertal children and of 17 pIU/mL and 13 pIU/mL in pubertal girls and boys, respectively, OR Prediabetes)
  • ALT greater than or equal to 40 U/L
  • Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.
  • Patients of childbearing potential agrees to use adequate one or more effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Patients who are taking medications that can affect insulin (e.g., metformin, corticosteroids), most be on a stable dosage for at least 3 months prior to enrollment of the trial.
  • Written informed consent from parent or legal guardian, assent from child.

Exclusion Criteria:

  • Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of >6.5 mg/dL at baseline
  • Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.
  • Patients unable to complete MRI or Labs required for the study.
  • Current participation in another clinical trial
  • Current participation in a weight loss program or obesity treatment program or clinic
  • Cancer or history of cancer within 5 years
  • Severe illness that required hospitalization in the last 60 days
  • Use of medications known to cause liver steatosis (TPN, amiodarone, chronic oral steroids, etc.)
  • Patients with implanted metal devices that are not compatible with magnetic resonance imaging (MRI).
  • Intellectual disability or major psychiatric disorder limiting informed assent
  • Clinical evidence of cirrhosis or advanced liver disease by any one of the following abnormal labs: (Hemoglobin less than 10 g/dL, White blood cell less than 3,500 cells/mm, Neutrophil count less than 1,500 cells/mm3 of blood, Platelets less than 130,000 cells/mm3 of blood, Direct bilirubin greater than 1.0 mg/dL)
  • Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range.
  • Albumin less than 3.2 g/dL
  • A history of international normalized ratio (INR) greater than 1.4
  • AST or ALT greater than 250 IU/dL.
  • Compensated or decompensated cirrhosis with evidence of portal hypertension.
  • Patients is pregnant or breastfeeding.
  • Patients who have been enrolled in a recent clinical trial and had the last dose of investigational product within 30 days or 5 half-lives of the study drug, whichever is longer.

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Essential Amino Acids Supplementation intervention

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Miriam B Vos, MD, MSPH

616-267-2100miriam.vos@msu.edu

Locations

Corewell Health West

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Renee Stuller, RN

616-391-2460renee.stuller@corewellhealth.org

Principal Investigator:

Miriam B Vos, MD, MSPH

More Information

Sponsor

Michigan State University

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • MASLD
  • Adolescents
  • Liver
  • Sugar
  • Amino acid supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michigan State University on 2026-06-01.