Lysine Metabolic Availability in Children

NCT ID: NCT04135040

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2021-12-05

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.

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.

Conditions

Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lysine metabolic availability

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

Group Type: EXPERIMENTAL

L-Amino Acid

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

L-Amino Acid

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rajavel Elango, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajavel Elango, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33025006 (View on PubMed)

Other Identifiers

H17-00452

Identifier Type: -

Identifier Source: org_study_id