Establishment of the Breast Milk Database in China

Sponsor
Heilongjiang Feihe Dairy Co. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03675204
Collaborator
(none)
1,800
26.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1800 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Establishment of the Breast Milk Database in China
Actual Study Start Date :
Oct 19, 2016
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Dec 30, 2018

Outcome Measures

Primary Outcome Measures

  1. Protein in breast milk [At enrollment]

    Protein in breast milk measured in percent (%)

Secondary Outcome Measures

  1. Osmotic pressure [At enrollment]

    Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk

  2. Fatty acids in breast milk [At enrollment]

    Fatty acids composition (mg/L) in breast milk

  3. Amino acids [At enrollment]

    Amino acids composition (mg/L) in breast milk

  4. Oligosaccharides [At enrollment]

    Oligosaccharides levels (mg/L) in breast milk

  5. Probiotics [At enrollment]

    Probiotics composition (species) measured using gene sequencing in breast milk;

  6. Vitamins [At enrollment]

    Vitamins composition (μg/L) in breast milk

  7. Minerals [At enrollment]

    Minerals composition (mg/L) in breast milk

  8. Hormones [At enrollment]

    Hormones composition (mg/L) in breast milk

  9. Dietary composition of participating mothers [At enrollment]

    Investigation on the dietary composition of participating mothers obtained using questionnaire

  10. Height of participating mothers [At enrollment]

    Height measurement (cm) of participating mothers

  11. Weight of participating mothers [At enrollment]

    Body weight measurement (kg) of participating mothers

  12. Age of participating mothers [At enrollment]

    Age (years) of participating mothers obtained using questionnaire

  13. Educational level of participating mothers [At enrollment]

    Educational level of participating mothers obtained using questionnaire

  14. Occupation of participating mothers [At enrollment]

    Occupation of participating mothers obtained using questionnaire

  15. Physical health condition of participating mothers [At enrollment]

    Physical health condition of participating mothers assessed by questionnaire

  16. Triglyceride [At enrollment]

    Triglyceride (mg/g) contents in breast milk

  17. Phospholipid [At enrollment]

    Phospholipid (mg/g) contents in breast milk

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Heilongjiang Feihe Dairy Co. Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heilongjiang Feihe Dairy Co. Ltd.
ClinicalTrials.gov Identifier:
NCT03675204
Other Study ID Numbers:
  • 16-SC-05-FC-001
First Posted:
Sep 18, 2018
Last Update Posted:
Jul 31, 2019
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 31, 2019