Clinical Trial: A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months

Brief Summary: This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.

Detailed Summary:

INTRODUCTION

Threonine is an indispensable AA that must come from dietary sources. It is critical in the production of mucins in the gut (Law, Bertolo et al. 2007) and contributes significantly to collagen, elastin and tooth enamel formation (Kramsch, Franzblau et al. 1971, Robinson, Lowe et al. 1975). The current adequate intake (AI) for threonine in infants proposed by the Institute of Medicine, Food and Nutrition Board, in the 2005 Dietary Reference Intakes (DRIs) for macronutrients is based on a factorial approach due to the lack of conclusive empirical data. Studies that lead to the determination of amino acid (AA) requirements for infants used the nitrogen analysis technique and were performed over 20 years ago (Snyderman, Norton et al. 1959). Methodological advances have made it possible to determine AA requirements in humans with a more precise technique (Zello, Wykes et al. 1995). However, no studies of threonine requirement in infants (1- 6mo of age) with the use of the newer stable-isotope methods have been reported.

To accurately determine amino acid requirements, it is necessary to provide a range of amino acid intakes. For ethical reasons, infants cannot be fed very low or high test amino acid diets for prolonged periods of time. The minimally invasive IAAO method, initially developed in adults in our laboratory (Zello, Pencharz et al. 1993) and now used internationally (Huang, Hogewind-Schoonenboom et al. 2011) to determine amino acid requirements, overcomes this problem. The IAAO method takes less than 24 hours to conduct and has been used safely in parenterally fed neonates, enterally fed neonates, children and adults.

Our laboratory determined the enteral requirement of threonine in piglets (Bertolo, Chen et al. 1998) which was 0.42g/kg/d. We are able to e
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months [ Time Frame: 12 months ]

Original Primary Outcome: Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months [ Time Frame: 12 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Hospital for Sick Children

Dates:
Date Received: January 29, 2015
Date Started: February 2016
Date Completion: September 2018
Last Updated: January 30, 2017
Last Verified: January 2017