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SMART Diets for MASLD

NCT07459504·1 site·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Miriam B Vos, MD, MSPH
CONTACT
616-267-2100 miriam.vos@msu.edu

Lead

Michigan State University

With

Emory University
Corewell Health West
National Heart, Lung, and Blood Institute (NHLBI)

Metabolic-dysfunction associated steatotic liver disease is defined as the presence of abnormal hepatic stored triglycerides (hepatic steatosis), with one or more of 5 cardiometabolic factors (increased body mass index or waist circumference, hyperglycemia, hypertriglyceridemia, or low HDL) and no other chronic liver disease. Pediatric hepatic steatosis is central to long-term metabolic and cardiovascular health because of the relation of hepatic steatosis to the development of other major diseases. Hepatic steatosis limits the normal metabolic role of insulin and plays a key role in the future development of the metabolic syndrome, and is the strongest predictor for the development of type 2 diabetes.

Age

11–17

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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.

You may not be if

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.

The record

StatusRecruiting

PhasePhase 2

Taking part102

StartedNov 2026

UpdatedNov 13, 2026

Conditions

Metabolic-dysfunction Associated Steatotic Liver Disease

Where1

Corewell Health West
Grand Rapids, Michigan, United States