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

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Treatment 2: Bolus (LNS); Other: Treatment 1: Control; Dietary Supplement: Treatment 3: Divided Dose (LNS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02464111

5R25TW009343-03 (U.S. NIH Grant/Contract)

723323-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Group 1

Experimental group

Description:

Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)

Group 2

Experimental group

Description:

Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)

Group 3

Experimental group

Description:

Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given Treatment 3: Divided Dose - LNS supplement provided in 3 doses

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)

Group 4

Experimental group

Description:

Treatment 2: Bolus - LNS supplement provided in one dose Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)

Group 5

Experimental group

Description:

Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 2: Bolus - LNS supplement provided in one dose Treatment 1: Control - no supplement given

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)

Group 6

Experimental group

Description:

Treatment 3: Divided Dose - LNS supplement provided in 3 doses Treatment 1: Control - no supplement given Treatment 2: Bolus - LNS supplement provided in one dose

Treatment:

Other: Treatment 1: Control

Dietary Supplement: Treatment 2: Bolus (LNS)

Dietary Supplement: Treatment 3: Divided Dose (LNS)