Davis, California 95616


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

723323-1


NCT ID:

NCT02464111


Secondary ID:

5R25TW009343-03


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

USDA, Western Human Nutrition Research Center


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: B


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Juliana A Haber, B.S.
Principal Investigator
USDA WHNRC, UC Davis
Primary Contact:Juliana A Haber, B.S.
9255482993
jahaber@ucdavis.edu
Backup Contact:Lindsay H Allen, Ph.D, R.D.
(530) 752-5276
lindsay.allen@ars.usda.gov

Study Dates

Start Date:May 2015
Completion Date:June 2016
Completion Type:Anticipated
Primary Completion Date:October 2015
Primary Completion Type:Anticipated
Verification Date:June 2015
Last Changed Date:June 2, 2015
First Received Date:April 22, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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 (Vis
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Maternal thiamin (vitamin B1) status
Time Frame:Measured once prior to first study visit (week 1)
Safety Issues:False
Description:Maternal thiamin (vitamin B1) will be measured in blood.
Outcome Type:Secondary Outcome
Measure:Maternal niacin (vitamin B5) status
Time Frame:Measured once prior to first study visit (week 1)
Safety Issues:False
Description:Maternal niacin (vitamin B5) will be measured in blood.
Outcome Type:Secondary Outcome
Measure:Maternal riboflavin (vitamin B2) status
Time Frame:Measured once prior to first study visit (week 1)
Safety Issues:False
Description:Maternal riboflavin (vitamin B2) will be measured in blood.
Outcome Type:Secondary Outcome
Measure:Maternal pyridoxal (vitamin B6) status
Time Frame:Measured once prior to first study visit (week 1)
Safety Issues:False
Description:Maternal pyridoxal (vitamin B6) will be measured in blood.
Outcome Type:Secondary Outcome
Measure:Maternal cobalamin (vitamin B12) status
Time Frame:Measured once prior to first study visit (week 1)
Safety Issues:False
Description:Maternal cobalamin (vitamin B12) status will be measured in blood.
Outcome Type:Primary Outcome
Measure: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 (Vis
Safety Issues:False
Description:We are observing the change in breast milk vitamin B1 over the course of 8 hours.
Outcome Type:Primary Outcome
Measure:Change in Niacin (vitamin B5) in Breast Milk
Time Frame:Breast milk niacin will be assessed in an 8-hour milk sample on each of three study visit days (Visi
Safety Issues:False
Description:We are observing the change in breast milk vitamin B5 over the course of 8 hours.
Outcome Type:Primary Outcome
Measure: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 (
Safety Issues:False
Description:We are observing the change in breast milk vitamin B2 over the course of 8 hours.
Outcome Type:Primary Outcome
Measure: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 (V
Safety Issues:False
Description:We are observing the change in breast milk vitamin B6 over the course of 8 hours.
Outcome Type:Primary Outcome
Measure: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 (V
Safety Issues:False
Description:We are observing the change in breast milk vitamin B12 over the course of 8 hours.

Study Interventions

Intervention Type:Other
Name:Treatment 1: Control
Description:No supplement provided.
Arm Name:Group 1
Intervention Type:Dietary Supplement
Name:Treatment 2: Bolus (LNS)
Description:One LNS supplement provided in a single bolus dose in the morning
Arm Name:Group 1
Intervention Type:Dietary Supplement
Name:Treatment 3: Divided Dose (LNS)
Description:One LNS supplement provided in 3 separate portions throughout the study visit
Arm Name:Group 1

Study Arms

Study Arm Type:Experimental
Arm Name:Group 6
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
Study Arm Type:Experimental
Arm Name:Group 5
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
Study Arm Type:Experimental
Arm Name:Group 4
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
Study Arm Type:Experimental
Arm Name:Group 3
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
Study Arm Type:Experimental
Arm Name:Group 2
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
Study Arm Type:Experimental
Arm Name:Group 1
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

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:USDA, Western Human Nutrition Research Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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