Completed

NCT Number: NCT01971671

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

To understand breast milk composition during different lactating stages.

Completed

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Health Science Center, Peking University

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

No intervention.

Other

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Acronym: MING

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 29, 2013
Registry last updated: Oct 29, 2013

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.