Breastfeeding and Obesity on Offspring Body Composition
NCT ID: NCT02535637
Last Updated: 2015-08-28
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
37 participants
OBSERVATIONAL
2010-06-30
2012-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mothers-Infant
Mothers who were planning to exclusively breastfeed for six months were enrolled into the study along with their infant.
Exclusively breastfeed
There is no intervention other than mothers must exclusively breastfeed.
Interventions
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Exclusively breastfeed
There is no intervention other than mothers must exclusively breastfeed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
6 Months
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
University of Oklahoma
OTHER
Responsible Party
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David A. Fields, PhD
Associate Professor
Principal Investigators
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David A Fields, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty
References
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Wolfs D, Lynes MD, Tseng YH, Pierce S, Bussberg V, Darkwah A, Tolstikov V, Narain NR, Rudolph MC, Kiebish MA, Demerath EW, Fields DA, Isganaitis E. Brown Fat-Activating Lipokine 12,13-diHOME in Human Milk Is Associated With Infant Adiposity. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e943-e956. doi: 10.1210/clinem/dgaa799.
Isganaitis E, Venditti S, Matthews TJ, Lerin C, Demerath EW, Fields DA. Maternal obesity and the human milk metabolome: associations with infant body composition and postnatal weight gain. Am J Clin Nutr. 2019 Jul 1;110(1):111-120. doi: 10.1093/ajcn/nqy334.
Fields DA, George B, Williams M, Whitaker K, Allison DB, Teague A, Demerath EW. Associations between human breast milk hormones and adipocytokines and infant growth and body composition in the first 6 months of life. Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):78-85. doi: 10.1111/ijpo.12182. Epub 2017 Feb 3.
Alderete TL, Autran C, Brekke BE, Knight R, Bode L, Goran MI, Fields DA. Associations between human milk oligosaccharides and infant body composition in the first 6 mo of life. Am J Clin Nutr. 2015 Dec;102(6):1381-8. doi: 10.3945/ajcn.115.115451. Epub 2015 Oct 28.
Other Identifiers
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15246
Identifier Type: -
Identifier Source: org_study_id
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