Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Recruiting · Aurora, Colorado
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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 this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Ages 13 to 18
- •Have NAFLD (non-alcoholic fatty liver disease), confirmed by fibroscan or liver biopsy within 6 months, or by a liver fat MRI result over 5.5%
- •Tanner stage 4–5
- •Have a BMI at or above the 85th percentile for their age and gender
- •Are not very active (less than 3 hours of moderate exercise per week)
🚫 You may not be able to join if…
- •Use certain medicines that can affect insulin sensitivity, including metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressants, or HIV medicines
- •Are currently pregnant or breastfeeding (pregnancy during the study means leaving the study)
- •Have diabetes (Hemoglobin A1C > 6.4%)
- •Have too low BMI percentile (below the 85th percentile) or a waist circumference > 200 cm
- •Have anemia (Hemoglobin < 11 mg/dL) or a major psychiatric/developmental disorder that limits informed consent
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 13–18
- ✓Have Obesity / overweight or Fatty liver disease (NASH/MASH)
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05935826 · Locations: Colorado