Skip to main content
OpenTrials
Completed

NCT Number: NCT06366204

Lysine Requirements During Lactation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

About this study

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 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. 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-[1-13C]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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Female
  • 20-40 years
  • Had a singleton pregnancy and is breastfeeding a single child.
  • Exclusively breastfeeding an infant 3 - 4 months of age OR complimentary. feeding an infant 9-10 months of age.

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 20 years of age or greater than 40 years of age.
  • Infants' 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.

Treatment and study plan

Dietary Lysine Intakes

Other

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.

Primary outcomes

  1. Carbon 13 Oxidation

    Time frame: 8 hours

    Urine and breath samples will be collected to measure the rate of L-[1-13C]phenylalanine oxidation.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.