Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.
The study includes a cross sectional and an interventional component. Maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner. The short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and LNS. Infants will be test-weighed during the LNS intervention in order to calculate the infant micronutrient intake from the control and LNS intervention days. Mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. All mothers will receive all treatments. The mothers will be invited to the clinic on 4 separate occasions. During the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. During the 2-4 visits, the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted milk collection will occur. Subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their meals throughout the day. Infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
No supplement provided.
One LNS supplement provided in a single bolus dose in the morning
One LNS supplement provided in 3 separate portions throughout the study visit
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States
Change in Cobalamin (vitamin B12) in Breast Milk
We are observing the change in breast milk vitamin B12 over the course of 8 hours.
Time frame: Breast milk cobalamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
Change in Pyridoxal (vitamin B6) in Breast Milk
We are observing the change in breast milk vitamin B6 over the course of 8 hours.
Time frame: Breast milk pyridoxal will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits/weeks 2, 3, & 4 will each be held approximately 1 week apart.
Change in Riboflavin (vitamin B2) in Breast Milk
We are observing the change in breast milk vitamin B2 over the course of 8 hours.
Time frame: Breast milk riboflavin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Change in Niacin (vitamin B3) in Breast Milk
We are observing the change in breast milk vitamin B5 over the course of 8 hours.
Time frame: Breast milk niacin will be assessed in an 8-hour milk sample on each of three study visit days (Visits 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
Change in Thiamin (vitamin B1) in Breast Milk
We are observing the change in breast milk vitamin B1 over the course of 8 hours.
Time frame: Breast milk thiamin will be assessed in an 8-hour milk sample on each of three study visit days (Visits/weeks 2, 3, and 4.) Study visits 2, 3, & 4 will each be held approximately 1 week apart.
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Maternal cobalamin (vitamin B12) status
Maternal cobalamin (vitamin B12) status will be measured in blood.
Time frame: Measured once prior to first study visit (week 1)
Maternal pyridoxal (vitamin B6) status
Maternal pyridoxal (vitamin B6) will be measured in blood.
Time frame: Measured once prior to first study visit (week 1)
Maternal riboflavin (vitamin B2) status
Maternal riboflavin (vitamin B2) will be measured in blood.
Time frame: Measured once prior to first study visit (week 1)
Maternal niacin (vitamin B3) status
Maternal niacin (vitamin B5) will be measured in blood.
Time frame: Measured once prior to first study visit (week 1)
Maternal thiamin (vitamin B1) status
Maternal thiamin (vitamin B1) will be measured in blood.
Time frame: Measured once prior to first study visit (week 1)
Change in Infant Milk Consumption
Infants will be test-weighed before and after each feed to calculate milk intake during the study visits. We are observing the change in breast milk intake over the course of 8 hours.
Time frame: Breast milk consumption for an 8-hour period will be assessed on each of three study visit days (Visits/weeks 2, 3, and 4). Study visits 2, 3, & 4 will each be held approximately 1 week apart.