Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women
NCT ID: NCT02464111
Last Updated: 2015-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-05-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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
Treatment 1: Control
No supplement provided.
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
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
Treatment 1: Control
No supplement provided.
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
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
Treatment 1: Control
No supplement provided.
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
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
Treatment 1: Control
No supplement provided.
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
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
Treatment 1: Control
No supplement provided.
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
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
Treatment 1: Control
No supplement provided.
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
Interventions
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Treatment 1: Control
No supplement provided.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of California, Davis
OTHER
Blum Center for Developing Economies
UNKNOWN
Fogarty International Center of the National Institute of Health
NIH
Center for the Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)
UNKNOWN
USDA, Western Human Nutrition Research Center
FED
Responsible Party
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Principal Investigators
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Juliana A Haber, B.S.
Role: PRINCIPAL_INVESTIGATOR
USDA WHNRC, UC Davis
Locations
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USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States
Countries
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References
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Donohue JA, Solomons NW, Hampel D, Shahab-Ferdows S, Orozco MN, Allen LH. Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial. Am J Clin Nutr. 2020 Sep 1;112(3):669-682. doi: 10.1093/ajcn/nqaa147.
Other Identifiers
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723323-1
Identifier Type: -
Identifier Source: org_study_id
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