Impact of Breastfeeding and Obesity on Offspring Body Composition and Growth at Six Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- The association of breast milk adipocytokines with infant body composition at one and 6-months of age.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The association of breast milk adipocytokines with infant body composition at one and 6-months of age.
时间窗: 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 association of breast milk adipocytokines with maternal body mass index at one and 6-months of age.
时间窗: 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.
次要结局
- The change in infant body composition (body fat and fat-free mass) from one to 6-months of age.(One to 6-months.)
- The change in breast milk adipocytokines levels from one to 6-months.(One to 6-months.)
研究者
David A. Fields, PhD
Associate Professor
University of Oklahoma