Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04135040
Status:
COMPLETED
Last Update Posted:
2019-10-24
First Post:
2018-06-04
Brief Title:
Lysine Metabolic Availability in Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Assessment of the Protein Quality of Cereal Grains in School-aged Children
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 worlds 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 lysines 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 lysines 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 its metabolic availability to develop accurate interventions that will have a better chance to meet childrens daily requirements
Given that childhood is a critical period for optimal growth and development a comprehensive study of lysines 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
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 worlds 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 lysines 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 lysines 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 its metabolic availability to develop accurate interventions that will have a better chance to meet childrens daily requirements
Given that childhood is a critical period for optimal growth and development a comprehensive study of lysines 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None