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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05935826
Phase
PHASE3
Status
Recruiting
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Conditions

  • Adolescent Obesity
  • Hepatic Steatosis
  • NAFLD

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jun 18, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Change in Hepatic Fat Fraction [ Time Frame: Baseline and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univeristy of Colorado Anschutz Medical CampusAuroraColorado80045
Yesenia Garcia Reyes, MS
[email protected]
720-777-6984
Melanie Cree, MD,PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Univeristy of Colorado Anschutz Medical Campus· Aurora, CO

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