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Trial record 1 of 1 for:    NCT01971671
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Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake (MING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01971671
First received: October 14, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose
To understand breast milk composition during different lactating stages.

Condition Intervention
Focus of Study is Healthy Chinese Lactating Mother 0-270 Days Other: no intervention.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
breask milk sample.

Enrollment: 560
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chinese lactating mother
no intervention.
Other: no intervention.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Chinese lactating mother 0-270 days after delivery (inclusive) will be enrolled.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Alcoholic.
  • Smokers.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971671

Locations
China, Beijing
Health Science Center, Peking University
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Nestlé
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01971671     History of Changes
Other Study ID Numbers: 11.14.NRC
Study First Received: October 14, 2013
Last Updated: October 23, 2013

ClinicalTrials.gov processed this record on August 18, 2017