SMART Diets for MASLD
Eligible age
11–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Michigan State University
You may qualify 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 qualify 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.)
Where it's recruiting
Grand Rapids
Source: ClinicalTrials.gov · NCT07459504 · last updated 2026-06-01