Uptake and Utilization of Amino Acids by Splanchnic Bed

Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed

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.

Study Overview

• Status: Completed
• Conditions: Healthy Males
• Intervention / Treatment: Other: Threonine Experimental: Study Period 1; Other: Lysine Experimental: Study Period 2

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Tracer isotope - L-[1-13C]lysine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (ESTIMATE): December 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• 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
• Other Study ID Numbers: 0019880597 (Part b)