Uptake and Utilization of Amino Acids by Splanchnic Bed

Healthy Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032616
• Other study ID #: 0019880597 (Part b)
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2009
• Last updated: August 1, 2013
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Males

Intervention

Other:
• Threonine Experimental: Study Period 1
Enteral and parenteral infusion of threonine isotope
• Lysine Experimental: Study Period 2
Both intravenous (iv) and intragastric (ig) Lysine isotopes.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath VCO2		-30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs	No
Primary	Blood CO2		-30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs	No