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

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Description

This study plans to investigate if taking a protein nutrition supplement (EAA) for 8 weeks may reduce fat that is stored in the liver. This will be compared to 8 weeks of placebo (a “fake” supplement that does not contain protein). Participants will be assigned randomly either the protein supplement or the placebo, similar to a flip of a coin. Neither the participant nor the study team will know which group they are assigned to during the study.. Participants will take the protein or placebo drinks twice a day for 8 weeks and we will measure changes in liver fat, body composition and blood tests.

Details
Age

Child to Adult

Eligibility

Ages 13-18 years, with fatty liver diseaseInclusion Criteria Ages 13-18, Tanner stage 4-5 Biopsy-documented hepatic steatosis per the steatosis grade. Grade 1-3 required for inclusion Diagnosis of 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. Some blood pressure medications, in particular beta- blockers, have direct effects on concentrations of hepatic fat, and this could confound results. Known liver disease other than NAFLD or AST or ALT >150 IU/L.

Locations

Brain Imaging Center (BIC)
Brain Imaging Center - BIC
Childrens Hospital Colorado
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Melanie Cree

Melanie Cree

Study ID

Protocol Number: 23-0690

More information available at ClinicalTrials.gov: NCT05935826

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