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AMINOS Study: Essential Amino Acids for Liver Fat in Teens

This study, called AMINOS, is looking at whether a protein supplement called Purity (Essential Amino Acid Supplement by Amino Co) can help reduce extra fat in the liver of teenagers. You might be able to join if you are 13-18 years old, have extra fat in your liver (hepatic steatosis or NAFLD), and meet certain criteria like having an MRI liver fat over 5.5%. The main goal is to see if participants who take Purity for 2 months have less liver fat compared to those who take a placebo (a 'fake supplement'). After these two months, all participants will receive Purity for an additional 10 months. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with 55 planned participants. It involves a 2-month period where participants are randomly assigned to receive either Purity or a placebo, followed by a 10-month open-label extension where all participants receive Purity.
What's involved
You would take a supplement twice daily for 2 months, followed by 10 months of the same supplement. You would have an MRI, a body x-ray, and blood draws at the beginning and end of the initial 2-month period.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 8 weeks for the primary endpoint, and then for an additional 10 months during the open-label extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05935826

Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

Completed
PHASE3Ages 13–18InterventionalTreatment
University of Colorado, Denver
~31 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Essential Amino Acid Supplement by Amino CoPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hepatic Fat Fraction
Measured over Baseline and 8 weeks

Conditions

Hepatic Steatosis
NAFLD
Adolescent Obesity

Explore related trials

Nonalcoholic Fatty Liver DiseaseObesity

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Melanie Cree, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Hepatic Fat FractionBaseline and 8 weeks

    Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.