SMART Diets for MASLD

Recruiting Phase 2 Interventional Study
Metabolic-dysfunction Associated Steatotic Liver Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
11 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
Michigan State University · Other
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About This Trial
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 he…
Trial Locations
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Eligibility 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,…
Contacts

Miriam B Vos, MD, MSPH

616-267-2100

miriam.vos@msu.edu

CONTACT