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Uptake and Utilization of Amino Acids by Splanchnic Bed

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Chapman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01032616
First received: December 11, 2009
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy Males
Other: Threonine Experimental: Study Period 1
Other: Lysine Experimental: Study Period 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Breath VCO2 [ Time Frame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs ] [ Designated as safety issue: No ]
  • Blood CO2 [ Time Frame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Period 1
AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences
Other: Threonine Experimental: Study Period 1
Enteral and parenteral infusion of threonine isotope
Other Name: Tracer Isotope - L-[1-13C]threonine
Experimental: Study Period 2
AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences
Other: Lysine Experimental: Study Period 2
Both intravenous (iv) and intragastric (ig) Lysine isotopes.
Other Name: Tracer isotope - L-[1-13C]lysine

Detailed Description:

We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Males

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032616

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Paul Pencharz, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Karen Chapman, Clinical Research Nurse Specialist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01032616     History of Changes
Other Study ID Numbers: 0019880597 (Part b)
Study First Received: December 11, 2009
Last Updated: August 1, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
splanchnic bed
theronine and lysine metabolism uptake
isotopes
metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males

ClinicalTrials.gov processed this record on November 20, 2014