A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in breast milk fat concentration by mid-infrared spectroscopy
研究概览
简要总结
This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≤4.5 months postpartum
- •BMI 30 - 50 kg/m2
- •≥ 18 years of age
- •Singleton pregnancy
- •Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
- •Mother has a breast pump
- •Mother is willing to collect breast milk for a 24 hour period.
排除标准
- •Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
- •Use of recreational drugs, tobacco, or alcohol
- •Use of medications or supplements for which breastfeeding is contraindicated
- •Child has internal metal which may be an NMR safety concern
研究组 & 干预措施
Mediterranean Meal Plan
This is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period.
干预措施: Mediterranean Diet (Other)
结局指标
主要结局
Change in breast milk fat concentration by mid-infrared spectroscopy
时间窗: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.
The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers.
次要结局
未报告次要终点