Metabolic Availability of Lysine From White Maize

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02018575
First received: December 17, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Lysine Bioavailability in White Corn Determined in Healthy Young Adult Men
Dietary Supplement: Crystaline Lysine from Amino Acid Mixture
Dietary Supplement: White cornmeal porridge
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official 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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Metabolic Availability of Lysine [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Metabolic Availability of Lysine [ Time Frame: 15 mins after intake of the fourth hourly meal (before tracer infusion) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Metabolic availability of Lysine [ Time Frame: 30 mins after intake of the fourth hourly meal (before tracer infusion) ] [ Designated as safety issue: No ]
    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.

  • Metabolic Availability of Lysine [ Time Frame: 45 mins after intake of the fourth hourly meal (before tracer infusion) ] [ Designated as safety issue: No ]
    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.

  • Metabolic Availability of Lysine [ Time Frame: Post Tracer Infusion (between 150 and 240 min of tracer infusion) ] [ Designated as safety issue: No ]
    4 breath samples will be taken to provide F13CO2 measurement (Level of Phenylalanine oxidation). Breath samples will be collected and analyzed for 13CO2 enrichment.


Estimated Enrollment: 7
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lysine Amino Acid
29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
Dietary Supplement: Crystaline Lysine from Amino Acid Mixture
Crystaline 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 cornmeal porridge
A cornmeal porrodge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018575

Contacts
Contact: Nazanin Noori, MD, PhD 4168137454 nazanin.noori@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G-1X8
Contact: Nazanin Noori, MD, PhD    4168137454    nazanin.noori@sickkids.ca   
Contact: Mahroukh Rafii, BSc    4168137454    mahroukh.rafii@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Paul B Pencharz, MD, PhD The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02018575     History of Changes
Other Study ID Numbers: 0019850580 amendment
Study First Received: December 17, 2013
Last Updated: December 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Lysine
White corn
Bioavailability
Amino acids

ClinicalTrials.gov processed this record on August 01, 2014