Not Yet RecruitingPhase 2

SMART Diets for MASLD

United States102 participantsStarted 2026-04-26

Plain-language 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.

Who can participate

Age range11 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 dia…

What they're measuring

Change in hepatic steatosis

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT07459504

SponsorCorewell Health West

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-26

Contact for this trial

Yvonne Edgerly

616-267-2100 Yvonne.Edgerly@corewellhealth.org