Metabolic Availability of Lysine From White Maize

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Dietary Supplement: Crystalline Lysine Amino Acid Mix; Dietary Supplement: White corn meal porridge

• Registration Number: NCT02018575
• Lead Sponsor: The Hospital for Sick Children

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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-11
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levels of lysine intake.	Crystalline Lysine Amino Acid Mix	Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).
levels of lysine intake.	White corn meal porridge	Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).

Primary Outcome Measures

Name	Time	Method
Metabolic Availability of Lysine	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 Outcome Measures

Name	Time	Method
Metabolic Availability of Lysine	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada