NCT05935826CompletedPhase 3
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 28 Jun 2023
- Start date
- 18 Jun 2024
- Primary completion date
- 10 Aug 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05935826
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 31
- From 18 Jun 2024 to the primary completion date, 10 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of blood pressure medications
Other illness
- Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
- Severe illness requiring hospitalization within 60 days
- Diagnosed major psychiatric or developmental disorder limiting informed consent
Lab values
- Diabetes, defined as Hemoglobin A1C \> 6.4%
- Anemia, defined as Hemoglobin \< 11 mg/dL
- Known liver disease other than NAFLD or AST or ALT \>150 IU/L
Age
- BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm
Other
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
- Implanted metal devices that are not compatible with MRI
Who the study is looking for
- 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
Age in the registry: 13 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.