Breastfeeding and Obesity on Offspring Body Composition

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535637
• Other study ID #: 15246
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: August 25, 2015
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2015
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 6 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Milk Collection
• Obesity

Intervention

Other:
• Exclusively breastfeed
There is no intervention other than mothers must exclusively breastfeed.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Mead Johnson Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association of breast milk adipocytokines with maternal body mass index at one and 6-months of age.	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.	No
Primary	The association of breast milk adipocytokines with infant body composition at one and 6-months of age.	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.	No
Secondary	The change in infant body composition (body fat and fat-free mass) from one to 6-months of age.	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.	No
Secondary	The change in breast milk adipocytokines levels from 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), TNFa (pg/mL), high-sensitivity C-reactive protein (pg/mL) will be determined in breast milk from one and 6-months.	One to 6-months.	No