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

N/ACompletedNCT01971671

Société des Produits Nestlé (SPN)560 enrolled

Overview

To understand breast milk composition during different lactating stages.

Study Type

OBSERVATIONAL

Enrollment

560

Conditions

Focus of Study is Healthy Chinese Lactating Mother 0-270 Days

Interventions

no intervention.OTHER

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Health Science Center, Peking University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery.

Macronutrient composition includes calories (kcal/ml), total protein, fat and carbohydrate (lactose) content in breast milk.

Time frame: 0-270 days after delivery

Secondary Outcomes

Other nutrient composition in breast milk of 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.

Time frame: 0-270 days after delivery.

Dietary pattern of lactating mothers of 0-270 days after delivery.

A one-time standardized 24-hour food recall survey, is utilized to access dietary pattern of subjects.

Time frame: 0-270 days after delivery.

Nutrients intake and adequacy of lactating mothers of 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).

Time frame: 0-270 days after delivery

Nutrition supplements intake status of lactating mothers of 0-270 days after delivery.

A one-time food frequency questionnaire (FFQ), designed to access nutritional supplement usage, is being utilized.

Time frame: 0-270 days after delivery.

Data from ClinicalTrials.gov

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