Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
University of Colorado, Denver
55 participants
Jun 18, 2024
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria10
- 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
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Interventions
2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA
2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05935826