Lysine Metabolic Availability in Children

Assessment of the Protein Quality of Cereal Grains in School-aged Children

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.

Study Overview

• Status: Completed
• Conditions: Children
• Intervention / Treatment: Dietary supplement: L-Amino Acid

Detailed Description

Purpose The purpose of this research project is to implement the minimally invasive Indicator Amino Acid Oxidation (IAAO) method in healthy school-aged children to measure the metabolic availability of the essential amino acid lysine obtained from commonly consumed cereal grains and their breakfast counterparts. Additionally, the difference in metabolic availability through complementation of breakfast cereals with milk will be assessed.

Hypothesis The use of the IAAO method will yield a higher lysine metabolic availability for those cereal grains that have the least amount of fibre in the food matrix. Combining the consumption of cereals with milk will increase the metabolic availability of lysine.

Justification Cereal grains and their derived products are the most commonly consumed food group around the world. From traditional foods such as steamed rice, corn tortillas, and wheat bread to relatively modern products like ready-to-eat breakfast cereals. Up to 80% of the energy intake in developing countries comes from this food group. Given that they are considered as a low protein quality food source, a considerable amount of the world's population could potentially be at risk of lysine deficiency. Especially, children living in underdeveloped countries where complementation with other food sources, such as legumes, dairy, or other animal products, is not an available option. Since lysine is the limiting amino acid in cereals, this study is of great importance not only for its nutritional value, but also for its social and economic impact.

Current lysine recommendations for school-aged children are based on factorial calculations performed on results of adult male studies. To develop the Lysine EAR (Estimated Average Requirement) for growing children, these studies use adult lysine maintenance requirements multiplied by estimated rates of protein deposition and the efficiency of this deposition. Additionally, these studies do not measure lysine's bioavailability, which will vary depending on the food sources and the processing techniques used to preserve them. With these limitations in mind, the IAAO method has the capacity to accurately measure amino acid metabolic availability in different populations groups, such as healthy and malnourished children. Metabolic availability refers to the amount of absorbed amino acids that are used for protein synthesis. It takes into account all amino acid losses from digestion, absorption, metabolic utilization, and endogenous losses.

Previously, this method was used to determine lysine metabolic availability of rice in healthy adults. This is the only study of this nature done for any human food source. Currently, there is no information available regarding lysine's metabolic availability from corn, wheat, milk and any breakfast cereal. Previously the IAAO method has successfully been implemented in healthy Canadian and Indian children to measure lysine requirements. Additionally, lysine requirement studies has been preformed in moderately undernourished Indian children with parasitic intestinal infections. The study conclusions were that, undernourished children require around 20% more lysine than their healthy counterparts. In these cases it is not only important to know the lysine content of a food source, but also it's metabolic availability, to develop accurate interventions that will have a better chance to meet children's daily requirements.

Given that childhood is a critical period for optimal growth and development, a comprehensive study of lysine's metabolic availability in commonly consumed cereal grains is needed to develop adequate interventions and recommendations, targeted to prevent stunting and other signs of malnourishment in at risk populations around the world.

Objective The general objective of this research project is to assess the degree in which cereal food sources can meet lysine amino acid requirements in healthy school-aged children.

The specific objective us to:

- Determine the metabolic availability of lysine from rice, corn, oats, black beans and milk using the IAAO method in healthy school-aged children.

Research Design This is a repeated measures study design involving 1 pre-study visit and 8 study visits approximately one week apart from each other.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4H4
      • BC Children's Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary lysine	Urine will be collected during the study day to measure urinary excretion of lysine.	8 hours, 2 samples at the beginning and end of the study day.

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Rajavel Elango, PhD, University of British Columbia

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): April 24, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Children; Lysine; IAAO; Cereal Grains
• Other Study ID Numbers: H17-00452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No