Metabolic Availability of Lysine From Rice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01474226
First received: November 10, 2011
Last updated: July 26, 2013
Last verified: July 2013

November 10, 2011
July 26, 2013
January 2011
November 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01474226 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Metabolic Availability of Lysine From Rice
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.

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.

Interventional
Phase 1
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Healthy Adults
  • 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
Experimental: Lysine Amino Acid
Interventions:
  • Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid Mix
  • Dietary Supplement: Cooked Rice containing Lysine
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.
 
Completed
5
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01474226
0019850580, CIHR, grant MT10321
No
Dr. Paul Pencharz, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Paul B Pencharz, MD, PhD The Hospital for Sick Children, Toronto, Canada
The Hospital for Sick Children
July 2013

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