RecruitingPhase 2NCT07459504

SMART Diets for MASLD

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

Sponsor

Michigan State University

Enrollment

102 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

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.

Eligibility

Min Age: 11 YearsMax Age: 17 Years

Inclusion Criteria8

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 Criteria18

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.

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Interventions

DRUGEssential Amino Acids Supplementation intervention

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

OTHERLow 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.