Location: Obesity and Metabolism Research
Project Number: 2032-51530-025-059-A
Project Type: Cooperative Agreement
Start Date: Oct 1, 2020
End Date: Jun 15, 2024
The ongoing MILQ (Mothers, Infants and Lactation Quality) study has successfully collected colostrum (at 2-3 days postpartum) and then breast milk from 1 month through 8.5 months postpartum from 1000 women in 4 countries. Milk samples were not collected during the first month postpartum because of investigator’s concern that participant burden would result in unacceptable rates of refusal to enroll. However, sample collection from 1 to 8.5 months has proceeded exceptionally well with fewer drop-outs than expected at all four sites. The Investigators have therefore received funds to conduct this follow-on, separate study of milk composition and volume between birth and 1 month postpartum. Having this information on milk composition and volume during the first month will enable us to: • Complete the otherwise continuous composition curves from 1 to 8.5 months with data from birth through 1 month. • Measure the average 14-day milk volume for each participant on a rolling basis between 2 to 3 days postpartum and 31 days postpartum. • Determine young infants’ nutrient intakes from milk. • Detect stronger associations between maternal status and milk concentrations. • Obtain Reference Values for nutrients, and data on metabolites, HMOs and bioactive proteins in early milk.
Colostrum and breast milk samples will be collected from well-nourished mothers, age 18 to 40 y, in a systematic, identical way in four countries. The 4 sites are Rio de Janeiro, Brazil; Copenhagen, Denmark; Dhaka, Bangladesh; and Bakau, The Gambia. This agreement refers only to funding for The Gambia site. Criteria for selection of these field sites are: mothers are healthy and well nourished but not consuming mineral-vitamin supplements during the third trimester of pregnancy or during lactation, or consuming substantial amounts of food highly fortified with micronutrients. Participant women will be enrolled during the last 2 to 3 months of pregnancy, from the same or nearby clinics/communities as the MILQ study. Eligibility/exclusion criteria will be same as in the MILQ study. These include normal birthweight and delivery, healthy, and a good quality diet. For this study we are assuming that we can pool the data across the 4 sites and need data from a total of 260 mothers in the time period. We will enroll ˜80 women per site with the goal of 65 per site completing. Colostrum will be collected (before 2-3 days postpartum) and mothers assigned randomly to have milk samples collected twice during 4 to 31 days postpartum, always close to 14 days apart. Group 1 would have collection at 2-3 days then during weeks 1 and 3, and Group 2, at 2-3 days then during weeks 2 and 4. This design will enable milk and other data to be collected on most days between 2 and 31 days postpartum i.e. rolling data collection across the study period. Milk volume will be measured with deuterated water using the dose-to-mother (DTM) method that we have employed successfully in the main MILQ study. Nutrients and other milk constituents will be measured in our laboratory at the Western Human Nutrition Research Center in Davis, California.