Metabolic Availability of Lysine From White Maize
Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From White Maize Protein, in Young Adult Men
1 other identifier
interventional
7
1 country
1
Brief Summary
Our objective is to determine the metabolic availability of Lysine in white maize using the indicator amino acid oxidation (IAAO) technique in adult men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedNovember 15, 2016
November 1, 2016
2.4 years
December 17, 2013
November 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Availability of Lysine
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 Outcomes (1)
Metabolic Availability of Lysine
15 mins after intake of the fourth hourly meal (before tracer infusion)
Other Outcomes (3)
Metabolic availability of Lysine
30 mins after intake of the fourth hourly meal (before tracer infusion)
Metabolic Availability of Lysine
45 mins after intake of the fourth hourly meal (before tracer infusion)
Metabolic Availability of Lysine
Post Tracer Infusion (between 150 and 240 min of tracer infusion)
Study Arms (1)
levels of lysine intake.
EXPERIMENTALRandomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).
Interventions
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.
A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
Eligibility Criteria
You may qualify if:
- Healthy Adult males (20-49 years old)
You may not qualify if:
- A history of recent weight loss or illness
- Use of any medication at the time of entry into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G-1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul B Pencharz, MD, PhD
The Hospital for Sick Children, Toronto, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute, The Hospital for Sick Children
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 23, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
November 15, 2016
Record last verified: 2016-11