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Can cutting carbs reverse fatty liver in teens? new study investigates

NCT ID NCT05268042

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests whether a moderately low-carb diet can reduce liver fat and improve how the body uses insulin in teenagers with non-alcoholic fatty liver disease (NAFLD) and obesity. About 80 teens aged 10-17 will follow either a carb-restricted or a low-fat diet for 6 months, with all meals provided for the first 12 weeks. The goal is to see if diet changes can help control the disease without medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

May 2022

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * clinical-pathological diagnosis of NAFLD and current evidence of active disease, which will be determined by the ongoing presence of hepatic steatosis estimated by diffusely echogenic liver via ultrasound suggestive of fatty liver. * age 10 -17 yrs * overweight or obese (BMI \>75th percentile). Exclusion Criteria: * pregnancy * HbA1c \>7% * history of parenteral nutrition * hepatic virus infections (HCV RNA-polymerase chain reaction negative; hepatitis A, B, C, D, E, and G; cytomegalovirus; and Epstein-Barr virus) * use of medications known to induce steatosis (e.g. valproate, amiodarone, or prednisone), elevate liver enzymes, or affect body weight and carbohydrate metabolism (within the last 6months) * autoimmune liver disease * metabolic liver disease * Wilson's disease * genetic conditions (e.g. glycogen storage disorder) leading to hepatic steatosis; * history of bariatric surgery * participants and parents/guardians unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures * currently receiving intense lifestyle modification treatment * estimated Glomerular Filtration Rate (eGFR) \<60 * alcohol, tobacco or recreational drug use * unable to undergo MRI.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-alcoholic fatty liver disease Obesity

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.