Actively Recruiting
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Led by University of Colorado, Denver · Updated on 2025-08-28
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on adolescents aged 13 to 18 who have extra fat stored in their liver, a condition known as non-alcoholic fatty liver disease (NAFLD). The study aims to find out if taking a protein supplement twice daily for two months can reduce liver fat compared to a placebo. This research is important because reducing liver fat may improve health in young people with overweight or obesity and NAFLD. Participants are randomly assigned to receive either an essential amino acid protein supplement or a placebo for two months without knowing which one they are taking. After this initial period, all participants are offered the protein supplement for an additional ten months in an open-label extension. During the study, participants will take their assigned supplement twice daily and be monitored regularly. Throughout the trial, participants will undergo MRI scans to measure liver fat, body x-rays to assess body composition, and blood tests. These assessments happen at the start and end of the two-month supplement period. The main outcome measured is the change in liver fat. Researchers will also look at changes in insulin resistance and liver enzymes to understand the supplement’s effects. The study lasts over a year, including the initial two months and the extended ten-month period.
CONDITIONS
Brief Title
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 13 to 18 years, Tanner stage 4 to 5
- Suspected or diagnosed non-alcoholic fatty liver disease (NAFLD) confirmed by fibroscan or liver biopsy within 6 months
- MRI liver fat greater than 5.5%
- Overweight or obese with BMI at or above 85th percentile for age and sex
- Sedentary lifestyle with less than 3 hours of moderate exercise per week
You will not qualify if you...
- Use of medications affecting insulin sensitivity such as metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressants, or HIV medications
- Currently pregnant or breastfeeding
- Severe illness requiring hospitalization within the past 60 days
- Diabetes with Hemoglobin A1C greater than 6.4%
- BMI percentile below 85th or waist circumference over 200 cm
- Anemia with Hemoglobin less than 11 mg/dL
- Major psychiatric or developmental disorder limiting consent
- Implanted metal devices incompatible with MRI
- Use of blood pressure medications
- Known liver disease other than NAFLD or elevated liver enzymes (AST or ALT over 150 IU/L)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants take a protein supplement or placebo twice daily for 2 months. Tests including MRI, body x-ray, and blood draws are done at the start and end of this period to measure liver fat and other health markers.
2 visits (baseline and end of treatment, in-person)
Duration - 10 months
All participants continue taking the protein supplement daily for an additional 10 months in an open-label extension phase.
Visits as needed during open-label extension
Trial Site Locations
Total: 1 location
1
Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
Y
Yesenia Garcia Reyes, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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