Clinical trial NCT03675204: Establishment of the Breast Milk Database in China
Official title: Establishment of the Breast Milk Database in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Milk Collection
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 1800
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy lactating mother of 25 \~ 35 years old who are currently breast-feeding infants of 15 \~180 days old. Subjects are equally distributed in the postpartum time period of 15\~35 days, 36\~65 days, 66\~95 days, 96\~125 days, 126\~55 days and 156\~185 days

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Protein in breast milk
timeFrame: At enrollment
Secondary outcomes:
measure: Osmotic pressure
timeFrame: At enrollment
measure: Fatty acids in breast milk
timeFrame: At enrollment
measure: Amino acids
timeFrame: At enrollment
measure: Oligosaccharides
timeFrame: At enrollment
measure: Probiotics
timeFrame: At enrollment
measure: Vitamins
timeFrame: At enrollment
measure: Minerals
timeFrame: At enrollment
measure: Hormones
timeFrame: At enrollment
measure: Dietary composition of participating mothers
timeFrame: At enrollment
measure: Height of participating mothers
timeFrame: At enrollment
measure: Weight of participating mothers
timeFrame: At enrollment
measure: Age of participating mothers
timeFrame: At enrollment
measure: Educational level of participating mothers
timeFrame: At enrollment
measure: Occupation of participating mothers
timeFrame: At enrollment
measure: Physical health condition of participating mothers
timeFrame: At enrollment
measure: Triglyceride
timeFrame: At enrollment
measure: Phospholipid
timeFrame: At enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Heilongjiang Feihe Dairy Co. Ltd.
name: Shilong Jiang
role: STUDY_DIRECTOR
References: