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

Phase 3

Recruiting

• Conditions: Hepatic Steatosis; NAFLD; Adolescent Obesity
• Interventions: Drug: Essential Amino Acid Supplement by Amino Co; Other: Placebo

• Registration Number: NCT05935826
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Study Start: 2024-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amino Acid Supplement	Essential Amino Acid Supplement by Amino Co	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
Change in Hepatic Fat Fraction	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%.

Secondary Outcome Measures

Name	Time	Method
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	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.
Change in alanine aminotransferase (ALT)	Baseline and 8 weeks	Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.
Change in aspartate aminotransferase (AST)	Baseline and 8 weeks	Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.

Trial Locations

Locations (1)

Univeristy of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States