NCT01474226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

November 10, 2011

Last Update Submit

July 26, 2013

Conditions

Keywords

lysinericebioavailability

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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))

  • 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))

  • 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))

Secondary Outcomes (1)

  • Metabolic Availability of Lysine

    Post Tracer Infusion (between 150 and 240 min of tracer infusion)

Study Arms (1)

Lysine Amino Acid

EXPERIMENTAL
Dietary Supplement: Amino Acid Crystalline Lysine Amino Acid MixDietary Supplement: Cooked Rice containing Lysine

Interventions

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.

Lysine Amino Acid

Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice

Lysine Amino Acid

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adult males (18 to 50years old)

You may not qualify if:

  • A history of recent weight loss or illness
  • Use of any medication at the time of entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G-1X8, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • Paul B Pencharz, MD, PhD

    The Hospital for Sick Children, Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute,The Hospital for Sick Children

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 18, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations