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Recruiting NCT05935826

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

Phase III Interventional Hepatic Steatosis NAFLD Adolescent Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Essential Amino Acid Supplement by Amino Co, Placebo.
Who it may be relevant to
Registry conditions: Hepatic Steatosis, NAFLD, Adolescent Obesity. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Drug Essential Amino Acid Supplement by Amino Co
    2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA
  • Other Placebo
    2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

Primary outcome measures

  • Change in Hepatic Fat Fraction [Time frame: Baseline and 8 weeks]
Secondary outcome measures (3)
  • Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Time frame: Baseline and 8 weeks]
  • Change in alanine aminotransferase (ALT) [Time frame: Baseline and 8 weeks]
  • Change in aspartate aminotransferase (AST) [Time frame: Baseline and 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Univeristy of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT05935826 · 23-0690 · R44DK135312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗