Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women



Status:Completed
Conditions:Food Studies
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:May 2015
End Date:August 2015

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- Mother 18-40 years of age

- Apparently healthy, with no acute illness

- Willing to stay in clinic for breast milk sampling, and adhere to all study
procedures

- 4-6 months of lactation and ≥ 8 breast feeding episodes per day (usual frequency is
>20 times/day)

- Last birth was a singleton birth

- Only breastfeeding one child

- Child is 4-6 months of age

Exclusion Criteria:

- Current supplement use (iron + folic acid excepted)

- Self reported mastitis or other breast infections

- Reported problems with breastfeeding which might affect study procedures

- Last birth was premature (>4 weeks pre-term by maternal report)

- Measured body mass index (BMI) of less than 18.5 or a measured mid upper arm
circumference (MUAC) of less than 12.5 cm

- Temporary- if the mother or her infant present with an acute illness, (for example
flu or diarrhea,) they will be rescheduled to return on a later date when both are
apparently healthy.

- Allergy to milk, milk products, or peanuts.
We found this trial at
1
site
?
mi
from
Davis, CA
Click here to add this to my saved trials