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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hepatic Steatosis, NAFLD, Adolescent Obesity

In brief

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.

Key facts

Study ID

NCT05935826

Run by

University of Colorado, Denver

People needed

55

Starts

2024-06-18

Expected to finish

2026-08-31

Last updated by the study team

2025-08-28

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univeristy of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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