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Completed

NCT Number: NCT02464111

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment 1: Control

Other

No supplement provided.

Treatment 2: Bolus (LNS)

Dietary Supplement

One LNS supplement provided in a single bolus dose in the morning

Treatment 3: Divided Dose (LNS)

Dietary Supplement

One LNS supplement provided in 3 separate portions throughout the study visit

Primary outcomes

  1. Change in Cobalamin (vitamin B12) in Breast Milk

    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.

    We are observing the change in breast milk vitamin B12 over the course of 8 hours.

  2. Change in Pyridoxal (vitamin B6) in Breast Milk

    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.

    We are observing the change in breast milk vitamin B6 over the course of 8 hours.

  3. Change in Riboflavin (vitamin B2) in Breast Milk

    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.

    We are observing the change in breast milk vitamin B2 over the course of 8 hours.

  4. Change in Niacin (vitamin B3) in Breast Milk

    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.

    We are observing the change in breast milk vitamin B5 over the course of 8 hours.

  5. Change in Thiamin (vitamin B1) in Breast Milk

    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.

    We are observing the change in breast milk vitamin B1 over the course of 8 hours.

Secondary outcomes

  1. Maternal cobalamin (vitamin B12) status

    Time frame: Measured once prior to first study visit (week 1)

    Maternal cobalamin (vitamin B12) status will be measured in blood.

  2. Maternal pyridoxal (vitamin B6) status

    Time frame: Measured once prior to first study visit (week 1)

    Maternal pyridoxal (vitamin B6) will be measured in blood.

  3. Maternal riboflavin (vitamin B2) status

    Time frame: Measured once prior to first study visit (week 1)

    Maternal riboflavin (vitamin B2) will be measured in blood.

  4. Maternal niacin (vitamin B3) status

    Time frame: Measured once prior to first study visit (week 1)

    Maternal niacin (vitamin B5) will be measured in blood.

  5. Maternal thiamin (vitamin B1) status

    Time frame: Measured once prior to first study visit (week 1)

    Maternal thiamin (vitamin B1) will be measured in blood.

  6. Change in Infant Milk Consumption

    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.

    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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • Blum Center for Developing Economies
  • Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)
  • Fogarty International Center of the National Institute of Health
  • University of California, Davis

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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