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

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 28, 2023

Keywords

ClinConnect Summary

The AMINOS Study is a clinical trial looking at how a special protein supplement affects fat in the liver of adolescents aged 13 to 18 who have extra fat stored in their liver, a condition known as non-alcoholic fatty liver disease (NAFLD). Participants in this study will be randomly divided into two groups: one group will receive the protein supplement, while the other will get a placebo, which is a fake supplement that does not contain any active ingredients. This part of the study will last for 2 months, after which everyone will receive the protein supplement for an additional 10 months. The goal is to see if the protein supplement helps reduce liver fat more than the placebo.

To be eligible for this study, participants must be between 13 and 18 years old, have been diagnosed with NAFLD within the last 6 months, and have a body mass index (BMI) in the overweight or obese range. They should also be relatively inactive, meaning they do not exercise more than 3 hours a week. However, some individuals may not qualify, such as those taking certain medications that affect blood sugar levels or those with other serious health issues. If you or someone you know fits this description and is interested in participating, this study could provide valuable insights into managing liver fat in adolescents.

Gender

ALL

Eligibility criteria

• • 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