Smart Diets for MASLD in teens
Official title: A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth
Run by Michigan State University · NCT07459504 · Data updated 2026-11-12
This phase 2 trial tests whether essential amino acids and/or a low-sugar diet can help teens with MASLD, high BMI, and liver fat see improvements.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Grand Rapids, Michigan) |
| Status | Recruiting |
| Started | June 2026 |
| Main results expected | December 26, 2029 |
| Study ends | December 26, 2030 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07459504 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents aged 11–17 with MASLD, BMI at or above the 85th percentile, liver fat ≥8% on MRI, and at least one cardiometabolic risk factor.
✕Probably not a fit
Teens without significant liver fat, without cardiometabolic risk factors, or with contraindications to the interventions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study uses a SMART design to adaptively test an essential amino acids supplement and a low-sugar diet in adolescents with MASLD. Eligible participants are 11–17 years old with elevated BMI and liver fat, as measured by MRI-PDFF. The trial is conducted at a single site in Grand Rapids, Michigan, with collaborators from multiple institutions and NHLBI support. Outcomes focus on changes in hepatic steatosis and cardiometabolic risk factors through a randomized, multi-arm, adaptive approach.
Why it matters
Potential benefit: If successful, the treatment could reduce liver fat and improve metabolic health in affected teens.
How similar studies have gone: Prior pilot data suggest potential benefit for both amino acids and low-sugar approaches in liver fat reduction, but this adaptive, confirmatory trial is a novel application in MASLD.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Corewell Health West
Grand Rapids, Michigan, United States Recruiting
Study contacts
- Principal investigator: Miriam B Vos, MD, MSPH — Michigan State University
- Study coordinator: Miriam B Vos, MD, MSPH
- Email: miriam.vos@msu.edu
- Phone: 616-267-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.