Text Size

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
  Purpose

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.


Condition Intervention Phase
Healthy Adults
 Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid Mix
Dietary Supplement: Cooked Rice containing Lysine
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 5
Study Start Date: January 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474226

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G-1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Paul B Pencharz, MD, PhD The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01474226     History of Changes
Other Study ID Numbers: 0019850580, CIHR, grant MT10321
Study First Received: November 10, 2011
Last Updated: November 17, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
lysine
rice
bioavailability

ClinicalTrials.gov processed this record on May 19, 2013