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Lysine Metabolic Availability in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04135040
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 24, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief Summary:
This study will evaluate how much of the essential amino acid lysine school-aged children are using for protein synthesis when consuming different cereal grains. Six healthy children between 6-10y will be recruited. They will be given cooked white rice, corn, oats, black beans, and milk. Using a minimally invasive technique, the amount of lysine that is available from cereal grain products will be determined. With the results from this research project accurate diet recommendations will be developed for children consuming cereal-based diets.

Condition or disease Intervention/treatment Phase
Children Dietary Supplement: L-Amino Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of the Protein Quality of Cereal Grains in School-aged Children
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lysine metabolic availability
Lysine metabolism from pure amino acids and cereal foods in children.
Dietary Supplement: L-Amino Acid
8 different lysine intakes (L-Amino Acid and food) will be tested for 8 hours each.

Primary Outcome Measures :
  1. 13 CO2 production [ Time Frame: 8 hours (1 study day) ]
    Breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath.

Secondary Outcome Measures :
  1. Urinary lysine [ Time Frame: 8 hours, 2 samples at the beginning and end of the study day. ]
    Urine will be collected during the study day to measure urinary excretion of lysine.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy school-aged children between the ages of 6-10y.
  • Normal weight.
  • Normal eating habits.

Exclusion Criteria:

  • Children under 6 years old, or over 10 years old.
  • Children who are currently ill (fever, cold, vomiting or diarrhea).
  • Children outside normal weight parameters (3rd - 85th percentiles for weight).
  • Children with claustrophobia.
  • Children currently or recently taking medication or antibiotics.
  • Children with food allergies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04135040

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Contact: Rajavel Elango, PhD 6048752000 ext 4911
Contact: Katia Caballero, PhD student 6048752000 ext 4607

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Canada, British Columbia
BC Children's Hospital Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Rajavel Elango, PhD    6048752000 ext 4911   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Rajavel Elango, PhD University of British Columbia
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Responsible Party: Rajavel Elango, PhD, Principal Investigator, University of British Columbia Identifier: NCT04135040    
Other Study ID Numbers: H17-00452
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Cereal Grains