The Mothers, Infants, and Lactation Quality (MILQ) Study: A Multi-Center Collaboration

Abstract

Little valid information is available on human milk nutrient concentrations, especially for micronutrients (MN), and there are no valid Reference Values (RVs) across lactation. In this multi-center collaborative study, RVs will be established for human milk nutrients across the first 8.5 months postpartum. Well-nourished, unsupplemented women in Bangladesh, Brazil, Denmark, and The Gambia (n = 250/site) were recruited during the third trimester of pregnancy. Milk, blood, saliva, urine, and stool samples from mothers and their infants are collected identically at three visits (1–3.49, 3.5–5.99, 6.0–8.49 months postpartum). Milk analyses include macronutrients, selected vitamins, trace- elements and minerals, iodine, metabolomics, amino acids, human milk oligosaccharides, and bioactive peptides. We measure milk volume; maternal and infant diets, anthropometry, and morbidity; infant development, maternal genome, and the infant and maternal microbiome. RVs will be constructed based on methods for the WHO Child Growth Standards and the Intergrowth-21st Project. Clinical trials.gov registration number: NCT03254329.

Associations between maternal adiposity and appetite-regulating hormones in human milk are mediated through maternal circulating concentrations and might affect infant outcomes

“…Two-hundred-and-twenty-three Danish mother-infant dyads participating the Mothers, Infants and Lactation Quality (MILQ) study (H-17015174) were included in the present study. The MILQ study is an international multi-center cohort study with the overall aim of developing reference values for microand macronutrient concentration in human milk (HM), and is described in detail elsewhere (34).…”

“…Daily infant milk intake at each of the three visits was estimated using 24-h test weighing. Information regarding birth, sociodemographic characteristics, maternal and infant morbidity and breastfeeding practices was obtained using questionnaires (34).…”

Investigating donor human milk composition globally to develop effective strategies for the nutritional care of preterm infants: Study protocol

“…We will use what are considered the most robust analytical methods for assessing human milk [ 30 ], which have not often been used when reporting the nutrient composition of DHM [ 6 ]. Vitamin and mineral analysis will occur at the USDA lab that is conducting a multi-site, international study to develop reference values for mother’s milk [ 20 ]; therefore, we will be able to directly compare our DHM values to the newly emerging reference values for mother’s milk. Several micronutrients that have not previously been reported for DHM will be assessed, including selenium, thiamin, riboflavin, niacin, and B12.…”

“…This sample size will provide a large enough database for simulating the impact of different random pooling scenarios (described in more detail in the section on statistical analysis). It also exceeds the sample size estimated to allow reporting of 95% confidence intervals at the 5 th and 10 th centiles without overlap (n = 255) [ 20 ], allowing us to provide robust estimates on the composition of human milk from US donors.…”

Using Community Ecology Theory and Computational Microbiome Methods To Study Human Milk as a Biological System

“…This study densely sampled and modeled the temporal development of the gut microbiome among 900 infants, which enabled the discovery and characterization of the structural and functional assembly of the microbiome in early life. In human milk, the Mothers, Infants and Lactation Quality (MILQ) study is a relevant longitudinal study of 1,000 mothers aimed to establish reference values for human milk nutrients and bioactives analyzed at 4 time points in the first 9 months of lactation ( 73 ). Of note, most of the statistical methods described above would require a denser sampling scheme (i.e., daily, weekly) to enable accurate inference and prediction.…”