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Establishment of the Breast Milk Database in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675204
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Milk Collection 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.

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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 : October 19, 2016
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : December 30, 2018

Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Protein in breast milk [ Time Frame: At enrollment ]
    Protein in breast milk measured in percent (%)


Secondary Outcome Measures :
  1. Osmotic pressure [ Time Frame: At enrollment ]
    Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk

  2. Fatty acids in breast milk [ Time Frame: At enrollment ]
    Fatty acids composition (mg/L) in breast milk

  3. Amino acids [ Time Frame: At enrollment ]
    Amino acids composition (mg/L) in breast milk

  4. Oligosaccharides [ Time Frame: At enrollment ]
    Oligosaccharides levels (mg/L) in breast milk

  5. Probiotics [ Time Frame: At enrollment ]
    Probiotics composition (species) measured using gene sequencing in breast milk;

  6. Vitamins [ Time Frame: At enrollment ]
    Vitamins composition (μg/L) in breast milk

  7. Minerals [ Time Frame: At enrollment ]
    Minerals composition (mg/L) in breast milk

  8. Hormones [ Time Frame: At enrollment ]
    Hormones composition (mg/L) in breast milk

  9. Dietary composition of participating mothers [ Time Frame: At enrollment ]
    Investigation on the dietary composition of participating mothers obtained using questionnaire

  10. Height of participating mothers [ Time Frame: At enrollment ]
    Height measurement (cm) of participating mothers

  11. Weight of participating mothers [ Time Frame: At enrollment ]
    Body weight measurement (kg) of participating mothers

  12. Age of participating mothers [ Time Frame: At enrollment ]
    Age (years) of participating mothers obtained using questionnaire

  13. Educational level of participating mothers [ Time Frame: At enrollment ]
    Educational level of participating mothers obtained using questionnaire

  14. Occupation of participating mothers [ Time Frame: At enrollment ]
    Occupation of participating mothers obtained using questionnaire

  15. Physical health condition of participating mothers [ Time Frame: At enrollment ]
    Physical health condition of participating mothers assessed by questionnaire

  16. Triglyceride [ Time Frame: At enrollment ]
    Triglyceride (mg/g) contents in breast milk

  17. Phospholipid [ Time Frame: At enrollment ]
    Phospholipid (mg/g) contents in breast milk


Biospecimen Retention:   Samples Without DNA
A minimum of 60ml of breast milk will be collected for each subject.


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675204


Sponsors and Collaborators
Heilongjiang Feihe Dairy Co. Ltd.
Investigators
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Study Director: Shilong Jiang Heilongjiang Feihe Dairy Co. Ltd.
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Responsible Party: Heilongjiang Feihe Dairy Co. Ltd.
ClinicalTrials.gov Identifier: NCT03675204    
Other Study ID Numbers: 16-SC-05-FC-001
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No