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Breastfeeding and Obesity on Offspring Body Composition

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ClinicalTrials.gov Identifier: NCT02535637
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
David A. Fields, PhD, University of Oklahoma

Brief Summary:
The purpose of this study is to explore the effect maternal obesity and breastfeeding play on infant body composition. The investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than breast fed infants from normal weight mothers. Furthermore, the investigators postulate that circulating maternal milk adipocytokines will positively correlate to total fat mass at six months of age.

Condition or disease Intervention/treatment
Obesity Breast Milk Collection Other: Exclusively breastfeed

Detailed Description:

The objective of this study is to determine if offspring from overweight/obese non-diabetic mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at a greater rate from ~ 1 month to 6 months of life compared to breastfed infants from normal weight mothers.

Specific Aim 1: Understand how maternal obesity and breast-feeding impact body composition of the offspring. Based upon the investigators preliminary data and counter to accepted dogma the hypothesis is at six months of age total fat mass, particularly in the trunk will be elevated at 6 months of age in infants whose mother was either overweight or obese vs. infants from normal weight mothers.

Specific Aim 2: Identify adipocytokines in breast milk. The postulate is breast milk from overweight and obese mothers will have greater levels of insulin, glucose, Ghrelin, IGF-1, IL-6, TNFα, high-sensitivity C-reactive protein, and lower Leptin levels than breast milk from normal weight mothers and will be correlated with offspring fat mass.

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age
Study Start Date : June 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Group/Cohort Intervention/treatment
Mothers-Infant
Mothers who were planning to exclusively breastfeed for six months were enrolled into the study along with their infant.
Other: Exclusively breastfeed
There is no intervention other than mothers must exclusively breastfeed.




Primary Outcome Measures :
  1. The association of breast milk adipocytokines with maternal body mass index at one and 6-months of age. [ Time Frame: One to 6-months. ]
    The associations between breast milk adipocytokines and maternal fatness (i.e. body mass index) will be determined at both one and 6-months.

  2. The association of breast milk adipocytokines with infant body composition at one and 6-months of age. [ Time Frame: One to 6-months. ]
    The associations between breast milk adipocytokines and infant body composition (i.e. total fat and fat-free mass and the percentage of body fat) will be determined at both one and 6-months.


Secondary Outcome Measures :
  1. The change in infant body composition (body fat and fat-free mass) from one to 6-months of age. [ Time Frame: One to 6-months. ]
    The change in infant body composition will be measured from 1 to 6-months. Body composition is defined as the change (in grams) in total fat mass, total fat-free mass and the percentage of fat mass (%fat).

  2. The change in breast milk adipocytokines levels from one to 6-months. [ Time Frame: One to 6-months. ]
    The change in leptin (pg/mL), insulin (pg/mL), glucose (mg/mL), ghrelin (pg/mL), IGF-1 (pg/mL), IL-6 (pg/mL), TNFα (pg/mL), high-sensitivity C-reactive protein (pg/mL) will be determined in breast milk from one and 6-months.



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Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 37 mothers whom exclusively breast fed to six-months. Participants (mothers/infant) included offspring from mothers with a singleton-term healthy pregnancy (37-40 weeks). Both vaginal and cesarean deliveries were included. Infants who are exclusively breastfed (defined as no formula in the last 20 days) prior to enrollment will be considered.
Criteria

Inclusion Criteria:

  • Gestational age between 37 and 41 weeks
  • Singleton birth
  • Infant in good health
  • 40±5 days old at enrollment
  • Infant is being exclusively breastfed (defined as fed directly from the breast or with mother's expressed milk and receiving no formula in the last 20 days prior to enrollment)
  • Mother of an infant being exclusively breastfed plans to continue this exclusive feeding from the time of enrollment until six months of age
  • Parent/caregiver demonstrates an understanding of the given information and ability to record the requested data
  • Having obtained informed consent of legal representative

Exclusion Criteria:

  • Congenital illness or malformation that affects infant feeding and/or growth
  • Significant pre-natal and/or post-natal disease
  • Infant has received any complementary feeding, i.e. any nutrition besides breast milk
  • In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
  • Currently participating in another clinical trial

Information from the National Library of Medicine

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): NCT02535637


Sponsors and Collaborators
University of Oklahoma
Mead Johnson Nutrition
Investigators
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Principal Investigator: David A Fields, PhD Faculty
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David A. Fields, PhD, Associate Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT02535637    
Other Study ID Numbers: 15246
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight