Metabolic Availability of Lysine From Rice

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT01474226

First received: November 10, 2011

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2011

Last Updated Date

November 17, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Metabolic Availability of lysine [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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.
Metabolic Availability of lysine [ Time Frame: 15 min after intake of the fourth hourly meal (before tracer infusion)) ] [ Designated as safety issue: No ]
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.
Metabolic Availability of lysine [ Time Frame: 30 min after intake of the fourth hourly meal (before tracer infusion)) ] [ Designated as safety issue: No ]
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.
Metabolic Availability of lysine [ Time Frame: 45 min after intake of the fourth hourly meal (before tracer infusion)) ] [ Designated as safety issue: No ]
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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01474226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metabolic Availability of Lysine [ Time Frame: Post Tracer Infusion (between 150 and 240 min of tracer infusion) ] [ Designated as safety issue: No ]

4 breath samples will be taken to provide F13CO2 measurement (Level of phenylalanine oxidation).Breath samples will be collected and analyzed for 13CO2 enrichment.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metabolic Availability of Lysine From Rice

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy Adults

Intervention ^ICMJE

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.
Dietary Supplement: Cooked Rice containing Lysine
Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice

Study Arm (s)

Experimental: Lysine Amino Acid

Interventions:

Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid Mix
Dietary Supplement: Cooked Rice containing Lysine

Publications *

Prolla IR, Rafii M, Courtney-Martin G, Elango R, da Silva LP, Ball RO, Pencharz PB. Lysine from cooked white rice consumed by healthy young men is highly metabolically available when assessed using the indicator amino Acid oxidation technique. J Nutr. 2013 Mar;143(3):302-6. doi: 10.3945/jn.112.166728. Epub 2013 Jan 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01474226

Other Study ID Numbers ^ICMJE

0019850580, CIHR, grant MT10321

Has Data Monitoring Committee

Responsible Party

The Hospital for Sick Children

Study Sponsor ^ICMJE

The Hospital for Sick Children

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Paul B Pencharz, MD, PhD

The Hospital for Sick Children, Toronto, Canada

Information Provided By

The Hospital for Sick Children

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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