Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 11 to 17

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

PhasePhase 2
Study typeInterventional
Ages11 Years to 17 Years
SexAll
Enrollment102 (estimated)
SponsorMichigan State University
Academic / other
Locations1 site (Grand Rapids, Michigan)
StatusRecruiting
StartedJune 2026
Main results expectedDecember 26, 2029
Study endsDecember 26, 2030
Registry record updatedJune 1, 2026
Trial IDNCT07459504 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.