Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05935826 · ClinicalTrials.gov registry record · Phase 3
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
A Phase 3 study of NAFLD and Adolescent Obesity, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05935826: Recruiting Phase 3 study of NAFLD and Adolescent Obesity, sponsored by University of Colorado, Denver.
NCT05935826 is a Phase 3 study of NAFLD and Adolescent Obesity that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 55 participants, below the 163-participant average among 26 other NAFLD trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05935826, a Phase 3 study of NAFLD and Adolescent Obesity, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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%.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Essential Amino Acid Supplement by Amino Co
Study Locations (1)
Colorado
- Univeristy of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2024-06-18 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What NCT05935826 shows while recruiting
NCT05935826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 163-participant average among 26 other NAFLD trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with NAFLD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05935826 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05935826 about?
NCT05935826 is a clinical study titled "Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)". 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. ...
What is the current status of trial NCT05935826?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2024-06-18. Estimated completion is 2026-08-31.
What conditions does trial NCT05935826 study?
This clinical trial studies the following conditions: NAFLD, Adolescent Obesity, Hepatic Steatosis.
What interventions are being tested in trial NCT05935826?
The interventions under investigation include: Placebo (OTHER), Essential Amino Acid Supplement by Amino Co (DRUG).
Who is sponsoring clinical trial NCT05935826?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05935826 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NAFLD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05935826's enrollment target sits among peer trials
55 17th of 26 higher than 9 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
RECRUITING
-
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
RECRUITING · Phase 2
-
Reversal of Lipid-Induced Insulin Resistance
RECRUITING · NA
-
Digoxin In NASH (CODIN)
RECRUITING · Phase 2
-
Bicalutamide Therapy in Young Women With NAFLD and PCOS
RECRUITING · Phase 1
-
Androgens and NAFLD Longitudinal Cohort Study
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI