Metabolic Availability of Lysine From Rice

July 26, 2013 updated by: Dr. Paul Pencharz, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G-1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lysine Amino Acid
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Availability of lysine
Time Frame: 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.
Baseline
Metabolic Availability of lysine
Time Frame: 15 min 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.
15 min after intake of the fourth hourly meal (before tracer infusion))
Metabolic Availability of lysine
Time Frame: 30 min 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.
30 min after intake of the fourth hourly meal (before tracer infusion))
Metabolic Availability of lysine
Time Frame: 45 min 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.
45 min after intake of the fourth hourly meal (before tracer infusion))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Availability of Lysine
Time Frame: Post Tracer Infusion (between 150 and 240 min of tracer infusion)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 18, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0019850580
  • CIHR, grant MT10321 (Other Grant/Funding Number: CIHR, grant MT10321)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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