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.

Eligibility

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.

Conditions2

Interventions1

Locations1 site

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