Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
University of Colorado, Denver
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.
Description
The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to…
Eligibility
- Age range
- 13–18 years
- Sex
- All
- Healthy volunteers
- No
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: m…
Interventions
- DrugEssential Amino Acid Supplement by Amino Co
2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA
- OtherPlacebo
2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA
Location
- Univeristy of Colorado Anschutz Medical CampusAurora, Colorado