NCT04135040

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

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 not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

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

June 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3.9 years

First QC Date

June 4, 2018

Last Update Submit

July 17, 2024

Conditions

Keywords

IAAOLysineChildrenCereal Grains

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

EXPERIMENTAL

Lysine metabolism from pure amino acids and cereal foods in children.

Dietary Supplement: L-Amino Acid

Interventions

L-Amino AcidDIETARY_SUPPLEMENT

8 different lysine intakes (L-Amino Acid and food) will be tested for 8 hours each.

Lysine metabolic availability

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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.

Study Officials

  • Rajavel Elango, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations