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

September 4, 2015 updated by: USDA, Western Human Nutrition Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit
Experimental: Group 2
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit
Experimental: Group 3
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit
Experimental: Group 4
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit
Experimental: Group 5
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit
Experimental: Group 6
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
Other: Treatment 1: Control
No supplement provided.
Dietary supplement: Treatment 2: Bolus (LNS)
One LNS supplement provided in a single bolus dose in the morning
Dietary supplement: Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured once prior to first study visit (week 1)
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.
Measured once prior to first study visit (week 1)
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.
Measured once prior to first study visit (week 1)
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.
Measured once prior to first study visit (week 1)
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.
Measured once prior to first study visit (week 1)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

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

Investigators

  • Principal Investigator: Juliana A Haber, B.S., USDA WHNRC, UC Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 723323-1
  • 5R25TW009343-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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