跳至主要内容
临床试验/NCT03675204
NCT03675204
已完成
不适用

Establishment of the Breast Milk Database in China

Heilongjiang Feihe Dairy Co. Ltd.0 个研究点目标入组 1,800 人2016年10月19日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Breast Milk Collection
发起方
Heilongjiang Feihe Dairy Co. Ltd.
入组人数
1800
主要终点
Protein in breast milk
状态
已完成
最后更新
6年前

概览

简要总结

Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.

详细描述

The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou. Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.

注册库
clinicaltrials.gov
开始日期
2016年10月19日
结束日期
2018年12月30日
最后更新
6年前
研究类型
Observational
性别
Female

研究者

发起方
Heilongjiang Feihe Dairy Co. Ltd.
责任方
Sponsor

入排标准

入选标准

  • Lactating mother 25 \~ 35 years old;
  • Breast-feeding infants (15 \~180 days old );
  • Physically healthy by self-evaluation;
  • Does not smoke;
  • Does not drink alcohol;
  • Have given birth to physically healthy infants;
  • Signed the informed consent forms.

排除标准

  • Being treated for gastrointestinal symptoms;
  • Suffering from mastitis;
  • Suffering from infectious diseases (tuberculosis, viral hepatitis and HIV infection);
  • Suffering from cardiovascular disease;
  • Suffering from metabolic diseases (such as diabetes);
  • Suffering from mental system diseases;
  • Suffering from cancer and other malignant diseases;
  • Having history of taking antibiotics;
  • Not able to answer the study questions;
  • Participating in any nutritional or pharmaceutical intervention study recently.

结局指标

主要结局

Protein in breast milk

时间窗: At enrollment

Protein in breast milk measured in percent (%)

次要结局

  • Fatty acids in breast milk(At enrollment)
  • Hormones(At enrollment)
  • Physical health condition of participating mothers(At enrollment)
  • Height of participating mothers(At enrollment)
  • Phospholipid(At enrollment)
  • Amino acids(At enrollment)
  • Oligosaccharides(At enrollment)
  • Minerals(At enrollment)
  • Weight of participating mothers(At enrollment)
  • Probiotics(At enrollment)
  • Vitamins(At enrollment)
  • Osmotic pressure(At enrollment)
  • Dietary composition of participating mothers(At enrollment)
  • Triglyceride(At enrollment)
  • Age of participating mothers(At enrollment)
  • Educational level of participating mothers(At enrollment)
  • Occupation of participating mothers(At enrollment)

相似试验