Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Recruiting · NCT05935826 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Essential Amino Acid Supplement by Amino CoPlacebo
What this trial is about
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 can take part
Age range
13 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Univeristy of Colorado Anschutz Medical Campus - Aurora, Colorado, United States