Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366204
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Lysine Requirements During Lactation
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Determining Dietary Lysine Requirements in Healthy Lactating Women Using the Indicator Amino Acid Oxidation Technique
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
The study aims to establish lysine requirements using the indicator amino acid oxidation IAAO method in women exclusively breastfeeding a single infant aged 3-4 months and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess The diets will be provided in a complete protein shake format meeting all nutrient requirements except for the test lysine intake Breath samples evaluate the indicators oxidation to determine protein synthesis in response to lysine intake Urine and one blood sample will be collected to assess metabolite concentrations
Detailed Description:
This study is a single-day intervention study where participants will be studied in a repeated measures design with an individual having the option of participating in up 4 test lysine intakes for each lactation stage A minimum of 10 women will be recruited and the investigators hope to retain the same women for 8 study days to minimize data variability
Potential participants will meet the researchers for a 1-hour preliminary assessment where the investigators will evaluate their eligibility to participate in the study During each study day the participants will randomly receive a lysine test intake ranging from deficient to excess The study day diets will consist of 8 hourly isocaloric and isonitrogenous meals in a protein shake each presenting 112 of the daily energy requirement The diets are composed of crystalline amino acid mixtures based on the composition of egg protein
A Carbon-13 13C stable isotope tracer L-1-13Cphenylalanine will be added to the 5th-8th meal The investigators will measure the rate of oxidation of this tracer expired in breath and the flux of this tracer by its enrichment in urine The investigators will also collect a single blood sample to measure lysine metabolites Lysine requirements will be determined by a two-phase linear regression crossover model on L-1-13Cphenylalanine tracer oxidation using mixed-models regression to take repeated measures into account The oxidation rate of the indicator amino acid exhibits a linear increase as the lysine intake rises until it reaches a plateau The point at which this steady state is reached signifies that the test amino acid is predominantly utilized for protein synthesis The primary endpoint is the lysine intake level at which the transition occurs from indicator oxidation linear increase to protein synthesis plateau
Potential participants will meet the researchers for a 1-hour preliminary assessment where the investigators will evaluate their eligibility to participate in the study During each study day the participants will randomly receive a lysine test intake ranging from deficient to excess The study day diets will consist of 8 hourly isocaloric and isonitrogenous meals in a protein shake each presenting 112 of the daily energy requirement The diets are composed of crystalline amino acid mixtures based on the composition of egg protein
A Carbon-13 13C stable isotope tracer L-1-13Cphenylalanine will be added to the 5th-8th meal The investigators will measure the rate of oxidation of this tracer expired in breath and the flux of this tracer by its enrichment in urine The investigators will also collect a single blood sample to measure lysine metabolites Lysine requirements will be determined by a two-phase linear regression crossover model on L-1-13Cphenylalanine tracer oxidation using mixed-models regression to take repeated measures into account The oxidation rate of the indicator amino acid exhibits a linear increase as the lysine intake rises until it reaches a plateau The point at which this steady state is reached signifies that the test amino acid is predominantly utilized for protein synthesis The primary endpoint is the lysine intake level at which the transition occurs from indicator oxidation linear increase to protein synthesis plateau
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