Metabolic Availability of Lysine From White Maize

Healthy Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018575
• Other study ID #: 0019850580 amendment
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2013
• Last updated: November 11, 2016
• Start date: December 2013
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 49 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	30 mins after intake of the fourth hourly meal (before tracer infusion)	No
Other	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.	45 mins after intake of the fourth hourly meal (before tracer infusion)	No
Other	Metabolic Availability of Lysine	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)	No
Primary	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	No
Secondary	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.	15 mins after intake of the fourth hourly meal (before tracer infusion)	No