Fat Globules in Breast Milk
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
研究概览
简要总结
The aims of this study is:
- To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
- To study the changes in globules distribution along one session of lactation and during the day.
Study design:
Subjects:
This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins.
Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk.
Participants will be asked to repeat the procedure one month later.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers nursing only babies aged 2-5 months.
- •Age: 20-45 years old.
- •Written informed consent.
排除标准
- •Nursing babies more than 5 months or less than 2 months.
- •Infants who consume breast milk replacement formulas on top of breast milk.
结局指标
主要结局
To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
To study the changes in globules distribution along one session of lactation and during the day.
次要结局
未报告次要终点