Determining lysine needs for breastfeeding women
Determining Dietary Lysine Requirements in Healthy Lactating Women Using the Indicator Amino Acid Oxidation Technique
This study is testing how much lysine breastfeeding women need while feeding their 3-4 month old babies to see if their needs change as the babies start eating solid foods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06366204 on ClinicalTrials.gov |
What this trial studies
This study aims to establish the lysine requirements for women who are exclusively breastfeeding infants aged 3-4 months, using the indicator amino acid oxidation (IAAO) method. Participants will undergo a series of dietary interventions where they will receive varying levels of lysine intake through protein shakes over multiple study days. The study will assess how maternal lysine needs change as infants transition to complementary feeding at 9-10 months. Breath, urine, and blood samples will be collected to evaluate protein synthesis and metabolite concentrations in response to lysine intake.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 20-40 who are exclusively breastfeeding a single infant aged 3-4 months or are transitioning to complementary feeding with a 9-10 month old.
Not a fit: Patients with significant health issues, metabolic disorders, or those on medications affecting lactation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the dietary needs of breastfeeding women, potentially improving maternal and infant health outcomes.
How similar studies have performed: While studies on dietary requirements during lactation exist, this specific approach using the IAAO method is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vancouver, British Columbia
- BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Rajavel Elango — University of British Columbia
- Study coordinator: Rajavel Elango, PhD
- Email: relango@bcchr.ubc.ca
- Phone: 604-875-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.