AMINOS: Treatment of Pediatric Hepatic Steatosis With Amino Acids

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935826

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

2 month amino acid trial in adolescents with biopsy proven NAFLD.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Steatosis NAFLD Adolescent Obesity	Dietary Supplement: Purity formulation by Amino Co Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Treatment of Pediatric Hepatic Steatosis With Amino Acids

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Amino Acid Supplement Treatment	Dietary Supplement: Purity formulation by Amino Co 2 months of twice daily consumption of Purity or Placebo
Placebo Comparator: Placebo Placebo	Dietary Supplement: Placebo Placebo powder

Arm

Intervention/Treatment

Active Comparator: Amino Acid Supplement

Treatment

Dietary Supplement: Purity formulation by Amino Co

2 months of twice daily consumption of Purity or Placebo

Placebo Comparator: Placebo

Placebo

Dietary Supplement: Placebo

Placebo powder

Outcome Measures

Primary Outcome Measures

Hepatic Fat [2 months]

Secondary Outcome Measures

HOMA-IR [2 months]
ALT [2 months]
AST [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hepatic Steatosis by biopsy

Exclusion Criteria:

Type 2 diabetes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05935826

Other Study ID Numbers:

23-0690

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Amino Acid Suppliment

Additional relevant MeSH terms:

Fatty Liver

Pediatric Obesity

Study Results

No Results Posted as of Jul 7, 2023