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RecruitingHepatic SteatosisNAFLDAdolescent Obesity

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

Eligible age

13–18 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this 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.

Sponsor: University of Colorado, Denver

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

Where it's recruiting

Colorado

Aurora

Source: ClinicalTrials.gov · NCT05935826 · last updated 2025-08-28