NCT05935826

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2024-06-18
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2023-07-07
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study