Lysine Requirements During Lactation

Breastfeeding Clinical Trial

Official title:

Determining Dietary Lysine Requirements in Healthy Lactating Women Using the Indicator Amino Acid Oxidation Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366204
• Other study ID #: H23-03119
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: Rajavel Elango, PhD
• Phone: 604-875-2000
• Email: relango[@]bcchr.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations.

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 we hope to retain the same women for 8 study days to minimize data variability.

Potential participants will meet us for a 1-hour preliminary assessment, where we 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 1/12 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-[1-13C]phenylalanine) will be added to the 5th-8th meal. We will measure the rate of oxidation of this tracer expired in breath and the flux of this tracer by its enrichment in urine. We 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-[1-13C]phenylalanine 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

Healthy biologically female adults 20-40 years of age with a singleton pregnancy exclusively breastfeeding an infant 3 - 4 months of age. Participants can choose to continue participation in late-stage lactation studies where all former inclusion criteria apply except the infant must be 9-10 months of age and have transitioned to complimentary feeding.

Exclusion Criteria:

• Participants not in good health or have a history of metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders.

• Participants that had major pregnancy or delivery complications (e.g., preeclampsia/ eclampsia, placenta previa, postpartum haemorrhage, neonatal intensive care, gestational diabetes).

• Participants with substance dependence issues (e.g., nicotine, alcohol, marijuana, illicit drugs).

• Participants that have had breast surgery that may impact lactation, lactogenesis or breastfeeding.

• Participants that use medications that affect lactation (e.g. estrogenic birth control, anti-dopaminergic drugs, Methyldopa) or other continuous prescription medication.

• Participants with a pre-pregnancy BMI below 18 kg/m² or above 28 kg/m².

• Participants who are below 19 years of age or greater than 40 years of age.

• Infant's weight and length are under 3rd or above the 97th percentile, using the World Health Organization (WHO) percentile growth chart.

• Infants born before 38 weeks or after 42 weeks of gestation.

• Infants who use infant formula milk.

• Infants with known metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders.

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive
• Lactation

Intervention

Other:
• Dietary Lysine Intakes
Participants consume 8 hourly meals that contain the assigned test lysine intake. Each meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.7 x Resting Energy Expenditure (REE) and adequate protein at 1.5 g.kg.d, to maintain a metabolic steady state. The meals are in the form of a crystalline amino acid protein shake, and nitrogenous free cookies.

Locations

Country	Name	City	State
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon 13 Oxidation	Urine and breath samples will be collected to measure the rate of L-[1-13C]phenylalanine oxidation.	8 hours