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

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.

Study Overview

• Status: Recruiting
• Conditions: NAFLD; Adolescent Obesity; Hepatic Steatosis
• Intervention / Treatment: Drug: Essential Amino Acid Supplement by Amino Co; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yesenia Garcia Reyes, MS; Phone Number: 720-777-6984; Email: yesenia.garciareyes@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Univeristy of Colorado Anschutz Medical Campus
      • Contact: Yesenia Garcia Reyes, MS; Phone Number: 720-777-6984; Email: yesenia.garciareyes@childrenscolorado.org
      • Principal Investigator: Melanie Cree, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amino Acid Supplement; 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	Drug: Essential Amino Acid Supplement by Amino Co; 2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA; Other Names: Essential Amino Acid Supplement (EAA); AMS22392
Placebo Comparator: Placebo; 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	Other: Placebo; 2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Melanie Cree, MD, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 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 (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Amino Acid Supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Liver Diseases; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Fatty Liver; Non-alcoholic Fatty Liver Disease; Pediatric Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• 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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No