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NCT Number: NCT02535637

Breastfeeding and Obesity on Offspring Body Composition

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.

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Key information

Conditions

Obesity Behavior Body Weight Breast Feeding Breast Milk Collection Breast Milk Expression Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exclusively breastfeed

Other

There is no intervention other than mothers must exclusively breastfeed.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 28, 2015
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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