Location: Obesity and Metabolism Research
Project Number: 2032-51530-025-058-A
Project Type: Cooperative Agreement
Start Date: Oct 1, 2020
End Date: Jun 15, 2024
Objective:
The ongoing MILQ study has successfully collected colostrum (at 2-3 days postpartum) and then breast milk from 1 month through 8.5 months postpartum. Milk samples were not collected during the first month because of investigator’s concern that adding milk collection (accompanied by a great deal of additional information on mothers and infants as collected at all visits) during the first few weeks after birth would result in unacceptable rates of refusal to enroll and early drop-outs during this stressful period. However, sample collection from 1 to 8.5 months has proceeded exceptionally well with fewer drop-outs than expected at all four sites. At this time the investigators believe that we could add a follow-on, separate study of milk composition and volume between birth and 1 month postpartum, and that this would be well-accepted by participants. 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.
Approach:
Colostrum and breast milk samples will be collected from well-nourished mothers, age 18 to 40 years, in a systematic, identical way in four countries. This agreement refers only to funding for the Bangladesh site. Criteria for selection of the field site 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. (Folic acid-iron supplements and fortification are permitted). 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 will enroll ˜80 women in the Bangladesh site with the goal of 65 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 and31 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 in Davis, California.
