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NCT Number: NCT05935826

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

Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Melanie Cree, MD,PhD

PRINCIPAL_INVESTIGATOR

Yesenia Garcia Reyes, MS

CONTACT

[email protected]

720-777-6984

About this study

The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement.

After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essential Amino Acid Supplement by Amino Co

Drug

2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA

Other names: Essential Amino Acid Supplement (EAA), AMS22392

Placebo

Other

2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

Primary outcomes

  1. Change in Hepatic Fat Fraction

    Time frame: Baseline 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%.

Secondary outcomes

  1. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: Baseline and 8 weeks

    An approximate measure of insulin sensitivity. Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.

  2. Change in alanine aminotransferase (ALT)

    Time frame: Baseline and 8 weeks

    Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.

  3. Change in aspartate aminotransferase (AST)

    Time frame: Baseline and 8 weeks

    Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.

Study contacts

Contact information is provided by the study sponsor or research team.

Yesenia Garcia Reyes, MS

CONTACT

[email protected]

720-777-6984

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: AMINOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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