Breastfeeding and Obesity on Offspring Body Composition

August 25, 2015 updated by: David A. Fields, PhD, University of Oklahoma

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
There is no intervention other than mothers must exclusively breastfeed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One to 6-months.
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.
One to 6-months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One to 6-months.
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.
One to 6-months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: David A Fields, PhD, Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 28, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 15246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Exclusively breastfeed

Subscribe