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A protein supplement may fight fatty liver in teens

NCT ID NCT05935826

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether an essential amino acid supplement can lower fat stored in the liver of teenagers with non-alcoholic fatty liver disease (NAFLD). Participants aged 13 to 18 will take the supplement or a placebo for two months, and researchers will measure liver fat with MRI scans. After that, everyone can take the supplement for ten more months to see if any benefit continues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an essential amino acid supplement
What this could lead to
If it works, this supplement could offer a simple, non-drug way to reduce liver fat in teenagers with fatty liver disease.
What could go wrong
The trial is small and early, so results may not apply to everyone. The supplement might not reduce liver fat more than a placebo, and long-term effects are unknown.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

31 people

The number who actually took part.

Started

Jun 2024

Finished

Aug 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

13 to 18 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 * Ages 13-18, Tanner stage 4-5 * Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \>5.5% * Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist * Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week * BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories Exclusion Criteria * Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications. * Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study * Severe illness requiring hospitalization within 60 days * Diabetes, defined as Hemoglobin A1C \> 6.4% * BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm * Anemia, defined as Hemoglobin \< 11 mg/dL * Diagnosed major psychiatric or developmental disorder limiting informed consent * Implanted metal devices that are not compatible with MRI * Use of blood pressure medications * Known liver disease other than NAFLD or AST or ALT \>150 IU/L

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatotic liver disease obesity disorder Pediatric Obesity

As listed by the trial registrant

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

Adolescent obesity Hepatic steatosis NAFLD

Contacts and locations

Locations

  • Univeristy of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

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