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

NCT05935826 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 23-0690R44DK135312
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Amino Acid Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Baseline and 8 weeks

• Change in alanine aminotransferase (ALT)

  Baseline and 8 weeks

• Change in aspartate aminotransferase (AST)

  Baseline and 8 weeks

Study Arms (2)

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

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

Other: Placebo

Interventions

Essential Amino Acid Supplement by Amino Co DRUG

2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA

Also known as: Essential Amino Acid Supplement (EAA), AMS22392

Amino Acid Supplement

Placebo OTHER

2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

Placebo

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Univeristy of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Pediatric Obesity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie Cree, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yesenia Garcia Reyes, MS

CONTACT

720-777-6984; yesenia.garciareyes@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participants will be randomized to the protein supplement or placebo for 8 weeks. After the 8-week period, there will be a 10-month open label extension to allow all participants to receive the protein supplement for 10-months.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)