Lysine Metabolic Availability in Children
Assessment of the Protein Quality of Cereal Grains in School-aged Children
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2021
CompletedJuly 19, 2024
July 1, 2024
3.9 years
June 4, 2018
July 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
13 CO2 production
Breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath.
8 hours (1 study day)
Secondary Outcomes (1)
Urinary lysine
8 hours, 2 samples at the beginning and end of the study day.
Study Arms (1)
Lysine metabolic availability
EXPERIMENTALLysine metabolism from pure amino acids and cereal foods in children.
Interventions
8 different lysine intakes (L-Amino Acid and food) will be tested for 8 hours each.
Eligibility Criteria
You may qualify if:
- Healthy school-aged children between the ages of 6-10y.
- Normal weight.
- Normal eating habits.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4, Canada
Related Publications (1)
Caballero K, Mandal R, Pratap-Singh A, Kitts DD, Ball RO, Pencharz PB, Courtney-Martin G, Elango R. Lysine Bioavailability in School-Age Children Consuming Rice Is Reduced by Starch Retrogradation. J Nutr. 2020 Dec 10;150(12):3208-3215. doi: 10.1093/jn/nxaa276.
PMID: 33025006DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Rajavel Elango, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2018
First Posted
October 22, 2019
Study Start
June 1, 2017
Primary Completion
April 24, 2021
Study Completion
December 5, 2021
Last Updated
July 19, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share data with other researchers