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Completed

NCT Number: NCT03675204

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.

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Key information

Conditions

Breast Milk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Protein in breast milk

    Time frame: At enrollment

    Protein in breast milk measured in percent (%)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Heilongjiang Feihe Dairy Co. Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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