Establishment of the Breast Milk Database in China

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.

Study Overview

• Status: Completed
• Conditions: Breast Milk Collection
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 1800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein in breast milk	Protein in breast milk measured in percent (%)	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osmotic pressure	Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk	At enrollment
Fatty acids in breast milk	Fatty acids composition (mg/L) in breast milk	At enrollment
Amino acids	Amino acids composition (mg/L) in breast milk	At enrollment
Oligosaccharides	Oligosaccharides levels (mg/L) in breast milk	At enrollment
Probiotics	Probiotics composition (species) measured using gene sequencing in breast milk;	At enrollment
Vitamins	Vitamins composition (μg/L) in breast milk	At enrollment
Minerals	Minerals composition (mg/L) in breast milk	At enrollment
Hormones	Hormones composition (mg/L) in breast milk	At enrollment
Dietary composition of participating mothers	Investigation on the dietary composition of participating mothers obtained using questionnaire	At enrollment
Height of participating mothers	Height measurement (cm) of participating mothers	At enrollment
Weight of participating mothers	Body weight measurement (kg) of participating mothers	At enrollment
Age of participating mothers	Age (years) of participating mothers obtained using questionnaire	At enrollment
Educational level of participating mothers	Educational level of participating mothers obtained using questionnaire	At enrollment
Occupation of participating mothers	Occupation of participating mothers obtained using questionnaire	At enrollment
Physical health condition of participating mothers	Physical health condition of participating mothers assessed by questionnaire	At enrollment
Triglyceride	Triglyceride (mg/g) contents in breast milk	At enrollment
Phospholipid	Phospholipid (mg/g) contents in breast milk	At enrollment

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Study Director: Shilong Jiang, Heilongjiang Feihe Dairy Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16-SC-05-FC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No