Uptake and Utilization of Amino Acids by Splanchnic Bed

NCT01032616 | Completed Phase 1

• 1 other identifier: 0019880597 (Part b)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids. This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.

Conditions

Healthy Males

Keywords

splanchnic bed; theronine and lysine metabolism uptake; isotopes; metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males

Outcome Measures

Primary Outcomes (2)

• Breath VCO2

  -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs

• Blood CO2

  -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs

Study Arms (2)

Study Period 1

EXPERIMENTAL

AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences

Other: Threonine Experimental: Study Period 1

Study Period 2

EXPERIMENTAL

AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences

Other: Lysine Experimental: Study Period 2

Interventions

Threonine Experimental: Study Period 1 OTHER

Enteral and parenteral infusion of threonine isotope

Also known as: Tracer Isotope - L-[1-13C]threonine

Study Period 1

Lysine Experimental: Study Period 2 OTHER

Both intravenous (iv) and intragastric (ig) Lysine isotopes.

Also known as: Tracer isotope - L-[1-13C]lysine

Study Period 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Males

You may not qualify if:

• History of inborn error of metabolism
• Presence of a chronic disease
• Have unusual dietary practices
• Has recently lost weight
• Receiving pharmacological therapy or hormonal treatment

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Study Officials

• Paul Pencharz, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Nurse Specialist

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

CA (1)