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Clinical Trials/NCT02535637
NCT02535637
Completed
Not Applicable

Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age

University of Oklahoma0 sites37 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Oklahoma
Enrollment
37
Primary Endpoint
The association of breast milk adipocytokines with infant body composition at one and 6-months of age.
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
February 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David A. Fields, PhD

Associate Professor

University of Oklahoma

Eligibility 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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • The change in infant body composition (body fat and fat-free mass) from one to 6-months of age.(One to 6-months.)
  • The change in breast milk adipocytokines levels from one to 6-months.(One to 6-months.)

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