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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Essential Amino Acid Supplement by Amino Co

2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA

OTHER

Placebo

2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

Locations (1)

Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, United States