Metabolism of Ornithine Phenylacetate

NCT03159390 | Completed

• 1 other identifier: 2014-0801
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic fate.

Conditions

Healthy

Keywords

dietary supplements

Outcome Measures

Primary Outcomes (1)

• metabolism of ornithine phenylacetate to glutamate and glutamine

  The incorporation of the N atoms of ORN into glutamate, and the quantitative contribution of both pathways will be traced, and when the enrichment of ORN and GLU is measured in muscle tissue, give an estimation of the importance of muscle OAT for this incorporation.

  4 study days that are 8 hours each

Study Arms (1)

phenylacetate salt of ornithine

EXPERIMENTAL

There are 4 study days of approximately 10 hours. Amino acid tracers (e.g., OP, PHE, TYR) will be provided via IV. The dosage of OP provided in this study 6 g in a period of 6 hours. 2 muscle biopsies will be completed on 2 of the study days.

Other: phenylacetate salt of ornithine

Interventions

phenylacetate salt of ornithine OTHER

phenylacetate salt of ornithine

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male \& female according to the investigator's or appointed staff's judgment
• Age 40-70 years (to be comparable with patients with liver cirrhosis: average 54.1 +/- 9.4 years)

You may not qualify if:

• Metabolic diseases including diabetes and hepatic or renal disorders
• Presence of acute illness or metabolically unstable chronic illness
• Failure to give informed consent
• (Possible) pregnancy
• Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results
• Unwilling to stop taking nutritional protein supplements within 5 days before test day
• History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
• Currently taking anti-thrombotics (i.e. medical indication) and cannot stop for 3-7 days prior to test days
• Allergy to local anesthetic

Sponsors & Collaborators

• Texas A&M University: lead
• Ocera Therapeutics: collaborator

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843-4253, United States

Location

Study Officials

• Marielle Engelen, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: February 3, 2015
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)