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.
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