Metabolic Availability of Lysine From Rice

Healthy Adults Clinical Trial

Official title:

Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Cooked Rice Protein in Adult Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474226
• Other study ID #: 0019850580
• Secondary ID: CIHR, grant MT10
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2011
• Last updated: July 26, 2013
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: July 2013
• 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

The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.

Description:

The investigators objective is to determine the metabolic availability (MA) of lysine in cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy Adult males (18 to 50years 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:
• Amino Acid Crystalline Lysine Amino Acid Mix
crystalline lysine from AA MIX (20, 40, and 60% of the mean lysine requirement of 35 mg/kg/d) Lysine will be given in the form of L-Lysine-HCl, Sigma-Aldrich Brand.
• Cooked Rice containing Lysine
Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice

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
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
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.	15 min after intake of the fourth hourly meal (before 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.	30 min after intake of the fourth hourly meal (before 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.	45 min after intake of the fourth hourly meal (before tracer infusion))	No
Secondary	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