- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935826
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study) (AMINOS)
April 15, 2024 updated by: University of Colorado, Denver
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yesenia Garcia Reyes, MS
- Phone Number: 720-777-6984
- Email: yesenia.garciareyes@childrenscolorado.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Ages 13-18, Tanner stage 4-5
- Biopsy-documented hepatic steatosis (HS) - per the steatosis grade. Grade 1-3 required for inclusion
- 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
Exclusion Criteria
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo powder
|
Active Comparator: Amino Acid Supplement
Treatment
|
2 months of twice daily consumption of Purity or Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
Change in alanine aminotransferase (ALT)
Time Frame: Baseline and 8 weeks
|
Target ALT levels in children are between 10-30 (U/L).
Higher values may indicate liver inflammation.
|
Baseline and 8 weeks
|
Change in aspartate aminotransferase (AST)
Time Frame: Baseline and 8 weeks
|
Target AST levels in children are between 10-35 (U/L).
Higher values may indicate liver inflammation.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-0690
- R44DK135312 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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