Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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%
Trial design
Treatments tested in this trial
- Essential Amino Acid Supplement by Amino Co
- Placebo
Treatment groups
55 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov