Hepatic SteatosisPhase 3AMINOSNCT05935826
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
A Phase 3 study testing Essential Amino Acid Supplement by Amino Co in people with Hepatic Steatosis and NAFLD, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Hepatic Steatosis, NAFLD, Adolescent Obesity
- What is being tested?
- Essential Amino Acid Supplement by Amino Co
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 10 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
- Severe illness requiring hospitalization within 60 days
- Diabetes, defined as Hemoglobin A1C > 6.4%
- BMI percentile less than the 85th percentile for age and sex. Waist circumference >200 cm
- Anemia, defined as Hemoglobin < 11 mg/dL
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- Diagnosed major psychiatric or developmental disorder limiting informed consent
- Implanted metal devices that are not compatible with MRI
- Use of blood pressure medications
- Known liver disease other than NAFLD or AST or ALT >150 IU/L
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About 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.
Read the detailed description
The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement.
After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
- Conditions
- Hepatic Steatosis, NAFLD, Adolescent Obesity
- Being tested
- Essential Amino Acid Supplement by Amino Co, Placebo
- Keywords
- Amino Acid Supplement
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino Acid Supplement by Amino CoDrug
Also called Essential Amino Acid Supplement (EAA), AMS22392
2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA
PlaceboOther
2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Supplement | Active comparator | Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants Receives: Drug: Essential Amino Acid Supplement by Amino Co |
| Placebo | Placebo comparator | Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatic Fat Fraction
Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
An approximate measure of insulin sensitivity. Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: Baseline and 8 weeks
Change in alanine aminotransferase (ALT)
Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.
Measured: Baseline and 8 weeks
Change in aspartate aminotransferase (AST)
Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start18 Jun 2024
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Cree, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935826
- Sponsor's protocol ID
- 23-0690
- Other IDs
- R44DK135312
- Acronym
- AMINOS
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
- ClinicalTrials.gov ID
- NCT05935826
- Acronym / sponsor ID
- AMINOS / 23-0690
- Conditions
- Hepatic Steatosis, NAFLD, Adolescent Obesity
- Keywords
- Amino Acid Supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement.
After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acid Supplement | Active comparator | Drug: Essential Amino Acid Supplement by Amino CoParticipants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants |
| Placebo | Placebo comparator | Other: PlaceboParticipants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
- Severe illness requiring hospitalization within 60 days
- Diabetes, defined as Hemoglobin A1C > 6.4%
- BMI percentile less than the 85th percentile for age and sex. Waist circumference >200 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Amino Acid Supplement by Amino CoAlso: Essential Amino Acid Supplement (EAA), AMS223922 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA | Drug | Amino Acid Supplement |
| Placebo2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA | Other | Placebo |
Primary outcome
Change in Hepatic Fat Fraction
Time frame: Baseline and 8 weeks
Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.
3 secondary outcomes
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline and 8 weeks
Change in alanine aminotransferase (ALT)
Time frame: Baseline and 8 weeks
Change in aspartate aminotransferase (AST)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatic Steatosis
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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
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Dietary Intervention Study on Liver Health in Young Adults
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RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Cree, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Essential Amino Acid Supplement by Amino Co in people with Hepatic Steatosis and NAFLD, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatic Fat Fraction (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.