NCT03805997已完成不适用
Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年4月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Level of α-linolenic acid in milk
研究概览
简要总结
During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food products that contain more ALA than conventional products, could impact nutritional and non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the implantation of the intestinal microbiota of the newborn, which is involved in preservation of short term and long term health of the child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women over 18;
- •≤ 28th week of amenorrhea
- •having a project of exclusive breastfeeding until at least the 45th day postpartum;
- •BMI before pregnancy between 18.5 and 30.0;
- •consuming frequently dairy products, eggs, meat (pork, beef, poultry);
- •accepting the consumption of all food products delivered;
- •written consent received and signed.
- •Non-inclusion criteria:
- •multiple pregnancy;
- •eating disorders or suspicion (defined by SCOFF score);
- •vegetarian, vegan or flexitarian;
- •allergic to food product(s) involved in the study;
- •home with more than 2 adults and 3 children (excluding foetus);
- •adults on legal protection (guardianship, trusteeship…), persons deprived of liberty;
排除标准
- •Interruption of breastfeeding before the 21st postpartum day
- •Prematurity: childbirth before the 37th week of amenorrhea
结局指标
主要结局
Level of α-linolenic acid in milk
时间窗: on the 21st postpartum day.
The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.
次要结局
- The α-linolenic acid level of breast milk(at the 45th postpartum day;)
- The immunoglobulin A and G content of breast milk(on the 21st and the 45th postpartum days;)
- The oligosaccharide content of breast milk(on the 21st and the 45th postpartum days)
- The fatty acid content of breast milk ;(on the 21st and the 45th postpartum days)
- The cytokine content of breast milk(on the 21st and the 45th postpartum days)
- The breast milk microbiota content(on the 21st and the 45th postpartum days)
- The lactoferrin content (antimicrobial factor) of breast milk(on the 21st and the 45th postpartum days;)
- The hormone content of breast milk(on the 21st and the 45th postpartum days)
- The breast milk lipidome(on the 21st postpartum day)
- The maternal milk metabolome(On the 21st postpartum day)
- the bacterial intestinal microbiota content from the feces of the newborn(on the 21st postpartum day;)
- Fatty acid content(before the 7th month of pregnancy and on the 21st postpartum day.)
研究者
研究点 (2)
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