Breastfeeding and Obesity on Offspring Body Composition

NCT ID: NCT02535637

Last Updated: 2015-08-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Obesity Breast Milk Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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David A. Fields, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 33135728 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30968129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28160457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26511224 (View on PubMed)

Other Identifiers

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15246

Identifier Type: -

Identifier Source: org_study_id

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