Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake (MING)
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|ClinicalTrials.gov Identifier: NCT01971671|
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : October 29, 2013
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|Condition or disease||Intervention/treatment|
|Focus of Study is Healthy Chinese Lactating Mother 0-270 Days||Other: no intervention.|
|Study Type :||Observational|
|Actual Enrollment :||560 participants|
|Official Title:||Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Nutrition Intake of Chinese Pregnant and Lactating Mothers, Infants and Young Children|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Chinese lactating mother
Other: no intervention.
- Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery. [ Time Frame: 0-270 days after delivery ]Macronutrient composition includes calories (kcal/ml), total protein, fat and carbohydrate (lactose) content in breast milk.
- Other nutrient composition in breast milk of 0-270 days after delivery. [ Time Frame: 0-270 days after delivery. ]Beside macronutrient composition, all major minerals, vitamins will be analyzed. In addition, functional compounds, such as human milk oligosaccharides (HMOs), total/free amino acids, lipid profiles, and microbiota, will be analyzed as well.
- Dietary pattern of lactating mothers of 0-270 days after delivery. [ Time Frame: 0-270 days after delivery. ]A one-time standardized 24-hour food recall survey, is utilized to access dietary pattern of subjects.
- Nutrients intake and adequacy of lactating mothers of 0-270 days after delivery. [ Time Frame: 0-270 days after delivery ]A one-time standardized 24-hour food recall survey, is utilized to access nutrient intakes and adequacy (by comparing existing local and international RDAs and DRIs databases).
- Nutrition supplements intake status of lactating mothers of 0-270 days after delivery. [ Time Frame: 0-270 days after delivery. ]A one-time food frequency questionnaire (FFQ), designed to access nutritional supplement usage, is being utilized.
Biospecimen Retention: Samples Without DNA
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Chinese lactating mother 0-270 days after delivery (inclusive).
- Healthy with neither acute disease nor history of hereditary disease, gestational diabetes, hypertension, other concomitant diseases, and disability.
- Parents/ caregiver is willing to comply with the study procedure.
- Having received oral and written information about the aims and procedures of the study.
- Having obtained the her informed consent.
- Subjects who are currently taking, or have taken in the last 4 weeks, or will take any medication.
- Subject who has history of psychopath and have no the dietary memory.
- Subjects who are suffering food allergy.
- Insufficient breast milk output according to the corresponding period after delivery.
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
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): NCT01971671
|Health Science Center, Peking University|
|Beijing, Beijing, China, 100191|
|Responsible Party:||Société des Produits Nestlé (SPN)|
|Other Study ID Numbers:||
|First Posted:||October 29, 2013 Key Record Dates|
|Last Update Posted:||October 29, 2013|
|Last Verified:||October 2013|