跳至主要内容
临床试验/NCT03245697
NCT03245697已完成不适用

Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia

University of Santiago de Compostela0 个研究点目标入组 102 人开始时间: 2016年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
主要终点
Fatty acid profile of breast milk in Galicia

研究概览

简要总结

Human milk is not a uniform body fluid, but quite the opposite, its composition changes continuously adapting to the requirements of the newborn. It can be considered as the gold standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during the first months of life. Additionally, its composition should be used as reference or guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In that connection, the nutritional status and dietary habits/patterns of the mother, along with certain genetic traits, exert also influence over breast milk. Considering all these facts, and their great impact on (present and future) infant health, detailed information of breast milk composition is required for specific populations, covering as many factors, elements and nutrients as possible.

In the present observational study, research is focused on breast milk in northwestern Spain, more precisely Galicia. In this context, the obtained data will serve to define the nutritional characteristics of breast milk from Galician women (interindividual variation), while at the same time evaluating the existence of specific features related to their particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the variables measured in this research project will be related with breast milk composition. Expected primary outcomes can be divided as follows: fatty acid profiles, mineral composition, essential amino acid profiles, microbiota and steroid hormones. The key influencing factors taken into account are: lactation characteristics and maternal diet.

Recruitment of participants is based on all the following criteria, with no exceptions: female, living in Galicia, lactating, > 18 years old, volunteer participation, written informed consent and agreement to complete questionnaires about lactation, diet and other socio-demographic factors. Samples are collected by participants, and stored at the University of Santiago de Compostela under a coded system so that it is impossible to identify the donor from whom the sample comes, with the exception of the investigators. The project is adhered to the principles of the Helsinki Declaration. Participants are allowed to withdraw their consent at any moment of the study.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • lactating
  • living in Galicia
  • voluntary participation

排除标准

  • 未提供

结局指标

主要结局

Fatty acid profile of breast milk in Galicia

时间窗: 2016

Fatty acid profile of breast milk collected from lactating women in Galicia, at different points postpartum; discussion on diet influence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PATRICIA REGAL

Professor and PhD researcher

University of Santiago de Compostela

相似试验