Breastfeeding and Obesity on Offspring Body Composition
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|ClinicalTrials.gov Identifier: NCT02535637|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : August 28, 2015
|Condition or disease||Intervention/treatment|
|Obesity Breast Milk Collection||Other: Exclusively breastfeed|
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|
|Actual Enrollment :||37 participants|
|Official Title:||Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Mothers who were planning to exclusively breastfeed for six months were enrolled into the study along with their infant.
Other: Exclusively breastfeed
There is no intervention other than mothers must exclusively breastfeed.
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535637
|Principal Investigator:||David A Fields, PhD||Faculty|