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Completed

NCT Number: NCT02018575

Metabolic Availability of Lysine From White Maize

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

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Key information

Conditions

Healthy Adults Callosities Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G-1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Crystalline Lysine Amino Acid Mix

Dietary Supplement

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.

White corn meal porridge

Dietary Supplement

A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

Primary outcomes

  1. 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 outcomes

  1. 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.

Other outcomes

  1. Metabolic availability of Lysine

    Time frame: 30 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.

  2. Metabolic Availability of Lysine

    Time frame: 45 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.

  3. Metabolic Availability of Lysine

    Time frame: Post Tracer Infusion (between 150 and 240 min of tracer infusion)

    4 breath samples will be taken to provide F13CO2 measurement (Level of Phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From White Maize Protein, in Young Adult Men

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2013
Registry last updated
Nov 15, 2016

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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