Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake

Completed

• Conditions: Focus of Study is Healthy Chinese Lactating Mother 0-270 Days
• Interventions: Other: no intervention.

• Registration Number: NCT01971671
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

To understand breast milk composition during different lactating stages.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Study First Posted: 2013-10-29
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 560

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chinese lactating mother	no intervention.	no intervention.

Primary Outcome Measures

Name	Time	Method
Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery.	0-270 days after delivery	Macronutrient composition includes calories (kcal/ml), total protein, fat and carbohydrate (lactose) content in breast milk.

Secondary Outcome Measures

Name	Time	Method
Other nutrient composition in breast milk of 0-270 days after delivery.	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.	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.	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.	0-270 days after delivery.	A one-time food frequency questionnaire (FFQ), designed to access nutritional supplement usage, is being utilized.

Trial Locations

Locations (1)

Health Science Center, Peking University; 🇨🇳 Beijing, Beijing, China