Understanding the Influence of Pregnancy on Breast Milk (Mom2Baby Pilot)
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|ClinicalTrials.gov Identifier: NCT02317653|
Recruitment Status : Completed
First Posted : December 16, 2014
Last Update Posted : February 15, 2018
|Condition or disease|
The Mom2Baby Pilot study will last about 4 months. Up to 20 pregnant women who were considered normal weight prior to pregnancy will be enrolled in the study. The infants born to these pregnant women will also be enrolled after birth. Archive blood, archive breast milk, and clinical assessment data from up to 20 participants who were considered overweight or obese at enrollment in the Expecting Success study conducted at Pennington Biomedical Research Center (NCT01610752) may be used to test the primary hypothesis as well as additional hypotheses.
We will measure levels of LC-PUFAS, pro-inflammatory biomarkers, and regulatory hormones (resistin, ghrelin) in serum (35,0-36,6 weeks gestation and 4,0-7,6 weeks postpartum) and breast milk (4,0-7,6 weeks postpartum) in normal weight (n=20) and overweight and obese (n=20) mothers. Blood serum and plasma and breast milk levels of these measures will be compared from pregnancy to postpartum within and between normal weight and overweight and obese women. Additional maternal procedures including questionnaires, anthropometrics, body composition measurements, energy intake measurement, and physical activity measurement will be investigated at 35,0-36,6 weeks gestation and 4,0-7,6 weeks postpartum. Infant procedures including anthropometrics, body composition measurements, stool collection, and energy intake measurement will be investigated at 0,1-0,6 weeks and 4,0-7,6 weeks postpartum.
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Mom2Baby Pilot: Understanding the Influence of Pregnancy on Breast Milk|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Archive blood, archive breast milk, and clinical assessment data from 15 participants who were considered overweight or obese at enrollment in the Expecting Success study conducted at Pennington Biomedical Research Center (NCT01610752) will be used to represent the overweight and obese sample for study investigations.
Up to 20 pregnant women who were considered normal weight (18.5 ≤ BMI ≤ 24.9 kg/m2) prior to pregnancy will be enrolled in the study.
- serum levels of n-3 to n-6 PUFA ratios during pregnancy will be compared to inflammatory markers and regulatory markers in blood and breast milk in both groups [ Time Frame: 1-2 months postpartum ]
- energy intake and diet quality assessed compositely with the Remote Food Photography Method developed at Pennington Biomedical during pregnancy will be compared to energy intake and diet quality in postpartum in both groups. [ Time Frame: 1-2 months postpartum ]
- n-3 and n-6 PUFA levels and inflammatory markers in mother's blood and breast milk will be assessed to test correlations to infants' body composition [ Time Frame: 1-2 months postpartum ]
Biospecimen Retention: Samples Without DNA
Maternal Blood Collection: approximately 60 mL of blood will be collected over 2 timepoints
Breast Milk Collection: approximately 50-100 mL of breast milk will be collected at 1 timepoint
Infant Stool Collection: 1 fresh infant stool sample will be collected at 1 timepoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317653
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Henry Nuss, Ph.D.||Louisiana State University Health Sciences Center in New Orleans|