Metabolic Availability of Lysine From White Maize

November 11, 2016 updated by: Dr. Paul Pencharz, The Hospital for Sick Children

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G-1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: levels of lysine intake.
Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 mins after intake of the fourth hourly meal (before tracer infusion)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 mins after intake of the fourth hourly meal (before tracer infusion)
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.
45 mins after intake of the fourth hourly meal (before tracer infusion)
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.
Post Tracer Infusion (between 150 and 240 min of tracer infusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (ESTIMATE)

December 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 11, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0019850580 amendment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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