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Completed

NCT Number: NCT01032616

Uptake and Utilization of Amino Acids by 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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Threonine Experimental: Study Period 1

Other

Enteral and parenteral infusion of threonine isotope

Other names: Tracer Isotope - L-[1-13C]threonine

Lysine Experimental: Study Period 2

Other

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

Other names: Tracer isotope - L-[1-13C]lysine

Primary outcomes

  1. Breath VCO2

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

  2. Blood CO2

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2009
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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