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

Summary

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.

Eligibility

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

Conditions4

Locations1 site

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