Establishment of the Breast Milk Database in China
- Conditions
- Breast Milk Collection
- Registration Number
- NCT03675204
- Lead Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1800
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Protein in breast milk At enrollment Protein in breast milk measured in percent (%)
- Secondary Outcome Measures
Name Time Method Amino acids At enrollment Amino acids composition (mg/L) in breast milk
Phospholipid At enrollment Phospholipid (mg/g) contents in breast milk
Fatty acids in breast milk At enrollment Fatty acids composition (mg/L) in breast milk
Hormones At enrollment Hormones composition (mg/L) in breast milk
Physical health condition of participating mothers At enrollment Physical health condition of participating mothers assessed by questionnaire
Height of participating mothers At enrollment Height measurement (cm) of participating mothers
Oligosaccharides At enrollment Oligosaccharides levels (mg/L) in breast milk
Minerals At enrollment Minerals composition (mg/L) in breast milk
Weight of participating mothers At enrollment Body weight measurement (kg) of participating mothers
Osmotic pressure At enrollment Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk
Probiotics At enrollment Probiotics composition (species) measured using gene sequencing in breast milk;
Vitamins At enrollment Vitamins composition (μg/L) in breast milk
Dietary composition of participating mothers At enrollment Investigation on the dietary composition of participating mothers obtained using questionnaire
Triglyceride At enrollment Triglyceride (mg/g) contents in breast milk
Age of participating mothers At enrollment Age (years) of participating mothers obtained using questionnaire
Educational level of participating mothers At enrollment Educational level of participating mothers obtained using questionnaire
Occupation of participating mothers At enrollment Occupation of participating mothers obtained using questionnaire