Metabolic Availability of Lysine From White Maize

Study Overview
=================
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.

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

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Dietary Supplement: Crystalline Lysine Amino Acid Mix
* Dietary Supplement: White corn meal porridge


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levels of lysine intake.<br>Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived). | Dietary Supplement: Crystalline Lysine Amino Acid Mix<br>* 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.<br>Dietary Supplement: White corn meal porridge<br>* A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lysine, bioavailability, amino acids, corn