Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)

Conditions
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Hepatic Steatosis, NAFLD, Adolescent Obesity

Intervention / Treatment
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* Dietary Supplement: Purity formulation by Amino Co
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amino Acid Supplement<br>Treatment | Dietary Supplement: Purity formulation by Amino Co<br>* 2 months of twice daily consumption of Purity or Placebo<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amino Acid Supplement