Protein Supplement for Fatty Liver in Teens
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Recruiting
Phase 3
Interventional Study
Hepatic Steatosis
NAFLD
Adolescent Obesity
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 13 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for teens aged 13-18 who have too much fat in their liver. Participants will take either a protein supplement or a fake supplement for two months to see which group has less fat in their liver.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 13 to 18 years old.
- I have been diagnosed with non-alcoholic fatty liver disease.
- I have extra fat in my liver shown by an MRI.
- I do less than 3 hours of exercise a week.
- My BMI is at least the 85th percentile for my age and gender.
- I have not lost more than 5% of my total body weight in the last 6 months.
- I am in Tanner stages 4-5.
You may not be able to join if
- I am currently pregnant or breastfeeding.
- I have a severe illness that required hospitalization in the last 60 days.
- I have diabetes.
- I have been diagnosed with a major psychiatric disorder.
- I use medications that affect insulin sensitivity.
- I have anemia.
- I have implanted metal devices that are not MRI compatible.
- I have a known liver disease other than NAFLD.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 pro…
Trial Locations
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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 diseas…
Contacts