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
114 weeks
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
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.
CONDITIONS
Official 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 4-5
- Suspected or diagnosed NAFLD confirmed by fibroscan or liver biopsy within 6 months prior, with less than 5% body weight loss
- MRI liver fat greater than 5.5%
- Diagnosis of NAFLD by a hepatologist
- Sedentary lifestyle with less than 3 hours of moderate exercise per week
- BMI at or above the 85th percentile for age and gender (overweight or obese)
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; pregnancy during the study will require withdrawal
- Severe illness requiring hospitalization within 60 days
- Diabetes with Hemoglobin A1C above 6.4%
- BMI percentile below the 85th for age and sex or waist circumference greater than 200 cm
- Anemia defined as Hemoglobin less than 11 mg/dL
- Major psychiatric or developmental disorders limiting informed consent
- Implanted metal devices incompatible with MRI
- Use of blood pressure medications
- Liver disease other than NAFLD or AST or ALT levels above 150 IU/L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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