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Establishment of the Breast Milk Database in China

Establishment of the Breast Milk Database in China

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03675204
Enrollment
1800
Registered
2018-09-18
Start date
2016-10-19
Completion date
2018-12-30
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Heilongjiang Feihe Dairy Co. Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Protein in breast milkAt enrollmentProtein in breast milk measured in percent (%)

Secondary

MeasureTime frameDescription
VitaminsAt enrollmentVitamins composition (μg/L) in breast milk
Osmotic pressureAt enrollmentOsmotic pressure (mmolOsm/Lkg.H2O) in breast milk
Fatty acids in breast milkAt enrollmentFatty acids composition (mg/L) in breast milk
Amino acidsAt enrollmentAmino acids composition (mg/L) in breast milk
OligosaccharidesAt enrollmentOligosaccharides levels (mg/L) in breast milk
ProbioticsAt enrollmentProbiotics composition (species) measured using gene sequencing in breast milk;
MineralsAt enrollmentMinerals composition (mg/L) in breast milk
Dietary composition of participating mothersAt enrollmentInvestigation on the dietary composition of participating mothers obtained using questionnaire
HormonesAt enrollmentHormones composition (mg/L) in breast milk
Weight of participating mothersAt enrollmentBody weight measurement (kg) of participating mothers
Age of participating mothersAt enrollmentAge (years) of participating mothers obtained using questionnaire
Educational level of participating mothersAt enrollmentEducational level of participating mothers obtained using questionnaire
Occupation of participating mothersAt enrollmentOccupation of participating mothers obtained using questionnaire
Physical health condition of participating mothersAt enrollmentPhysical health condition of participating mothers assessed by questionnaire
TriglycerideAt enrollmentTriglyceride (mg/g) contents in breast milk
PhospholipidAt enrollmentPhospholipid (mg/g) contents in breast milk
Height of participating mothersAt enrollmentHeight measurement (cm) of participating mothers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026