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NCT07459504 · ClinicalTrials.gov registry record · Phase 2

SMART Diets for MASLD

A Phase 2 study, sponsored by Michigan State University.

Recruiting
Registry status
Phase 2
Development phase
102
Enrollment target

NCT07459504: Recruiting Phase 2 study, sponsored by Michigan State University.

NCT07459504 is a Phase 2 study that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07459504, a Phase 2 study, is actively recruiting participants, sponsored by Michigan State University.

RECRUITING
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

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.

Primary Outcome

Change in hepatic steatosis by magnetic resonance imaging (MRI)

Interventions

  • DRUG Essential Amino Acids Supplementation intervention
  • OTHER Low sugar diet

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2026-06
Est. Completion 2030-12-26
Phase Phase 2
Michigan State University

120 total trials

What NCT07459504 shows while recruiting

NCT07459504 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 2 interventions - of which Essential Amino Acids Supplementation intervention is the first listed.

NCT07459504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07459504 about?

NCT07459504 is a clinical study titled "SMART Diets for MASLD". 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 increas...

What is the current status of trial NCT07459504?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2026-06. Estimated completion is 2030-12-26.

What interventions are being tested in trial NCT07459504?

The interventions under investigation include: Essential Amino Acids Supplementation intervention (DRUG), Low sugar diet (OTHER).

Who is sponsoring clinical trial NCT07459504?

This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07459504's enrollment target sits among peer trials

102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07459504, the US trial registry maintained by the National Library of Medicine. NCT07459504 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.