Lysine Requirements During Lactation

Launched by UNIVERSITY OF BRITISH COLUMBIA · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the nutritional needs of breastfeeding mothers, specifically focusing on an important building block of protein called lysine. The study will help determine how much lysine a mother needs while exclusively breastfeeding her 3 to 4-month-old baby, and how those needs change when the baby starts eating solid foods around 9 to 10 months. Participants will follow a special diet provided in the form of protein shakes, with different amounts of lysine included. Researchers will measure how the body responds to this lysine intake by analyzing breath, urine, and blood samples.

To participate, women must be healthy, aged 20 to 40, and either exclusively breastfeeding a single baby aged 3 to 4 months or feeding a baby aged 9 to 10 months who is starting on solid foods. The study will not accept women with certain health issues, those who have had complications during pregnancy, or those whose infants have specific health concerns. If eligible, participants can expect to consume the provided shakes during study days and provide samples to help researchers understand lysine requirements better. This study aims to improve nutritional guidelines for breastfeeding mothers, ensuring both they and their babies get the nutrients they need.

Gender

FEMALE

Eligibility criteria

• 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.