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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464111
• Other study ID #: 723323-1
• Secondary ID: 5R25TW009343-03
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: September 4, 2015
• Start date: May 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Malnutrition

Intervention

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
• Treatment 3: Divided Dose (LNS)
One LNS supplement provided in 3 separate portions throughout the study visit

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (5)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Blum Center for Developing Economies, Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM), John E. Fogarty International Center (FIC), University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cobalamin (vitamin B12) in Breast Milk	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.	No
Primary	Change in Pyridoxal (vitamin B6) in Breast Milk	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.	No
Primary	Change in Riboflavin (vitamin B2) in Breast Milk	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.	No
Primary	Change in Niacin (vitamin B3) in Breast Milk	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.	No
Primary	Change in Thiamin (vitamin B1) in Breast Milk	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.	No
Secondary	Maternal cobalamin (vitamin B12) status	Maternal cobalamin (vitamin B12) status will be measured in blood.	Measured once prior to first study visit (week 1)	No
Secondary	Maternal pyridoxal (vitamin B6) status	Maternal pyridoxal (vitamin B6) will be measured in blood.	Measured once prior to first study visit (week 1)	No
Secondary	Maternal riboflavin (vitamin B2) status	Maternal riboflavin (vitamin B2) will be measured in blood.	Measured once prior to first study visit (week 1)	No
Secondary	Maternal niacin (vitamin B3) status	Maternal niacin (vitamin B5) will be measured in blood.	Measured once prior to first study visit (week 1)	No
Secondary	Maternal thiamin (vitamin B1) status	Maternal thiamin (vitamin B1) will be measured in blood.	Measured once prior to first study visit (week 1)	No
Secondary	Change in Infant Milk Consumption	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.	No