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

NCT05935826 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-08-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Melanie Cree, MD, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935826 on ClinicalTrials.gov