Metabolic Availability of Lysine From White Maize

Overview

Our objective is to determine the metabolic availability of Lysine in white maize using the indicator amino acid oxidation (IAAO) technique in adult men.

Full Title of Study: “Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From White Maize Protein, in Young Adult Men”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Health Services Research
  • Masking: None (Open Label)
• Study Primary Completion Date: May 2016

Detailed Description

Our objective is to determine the metabolic availability of Lysine in white maize. 7 young, healthy, male adults will receive graded levels (29, 37,46 and 54%) of lysine requirement of 35 mg/kg/d as a crystalline AA mixture and a porridge of white cornmeal protein respectively.

Interventions

• Dietary Supplement: Crystalline Lysine Amino Acid Mix
  • Crystalline Lysine from Amino Acid Mixture in amount of 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
• Dietary Supplement: White corn meal porridge
  • A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

Arms, Groups and Cohorts

• Experimental: levels of lysine intake.
  • Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).

Clinical Trial Outcome Measures

Primary Measures

• Metabolic Availability of Lysine
  • Time Frame: Baseline
  • 3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of Phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.

Secondary Measures

• Metabolic Availability of Lysine
  • Time Frame: 15 mins after intake of the fourth hourly meal (before tracer infusion)
  • 3 breath samples will be taken to provide a baseline F13CO2 measurement (Level of Phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.

Participating in This Clinical Trial

Inclusion Criteria

• Healthy Adult males (20-49 years old) Exclusion Criteria:

• A history of recent weight loss or illness – Use of any medication at the time of entry into the study

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • The Hospital for Sick Children
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr. Paul Pencharz, Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute, The Hospital for Sick Children – The Hospital for Sick Children
• Overall Official(s)
  • Paul B Pencharz, MD, PhD, Principal Investigator, The Hospital for Sick Children, Toronto, Canada