Clinical trial NCT01971671: Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study is Healthy Chinese Lactating Mother 0-270 Days
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-10-29
Enrollment: 560
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Chinese lactating mother 0-270 days after delivery (inclusive) will be enrolled.

Brief summary: To understand breast milk composition during different lactating stages.


Eligibility 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.

Primary outcomes:
measure: Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery.
timeFrame: 0-270 days after delivery
Secondary outcomes:
measure: Other nutrient composition in breast milk of 0-270 days after delivery.
timeFrame: 0-270 days after delivery.
measure: Dietary pattern of lactating mothers of 0-270 days after delivery.
timeFrame: 0-270 days after delivery.
measure: Nutrients intake and adequacy of lactating mothers of 0-270 days after delivery.
timeFrame: 0-270 days after delivery
measure: Nutrition supplements intake status of lactating mothers of 0-270 days after delivery.
timeFrame: 0-270 days after delivery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Health Science Center, Peking University
state: Beijing
Study officials:
References:
citation: Yu K, Xue Y, Zhao W, Zhao A, Li W, Zhang Y, Wang P. Translation of nutrient recommendations into personalized optimal diets for Chinese urban lactating women by linear programming models. BMC Pregnancy Childbirth. 2018 Sep 18;18(1):379. doi: 10.1186/s12884-018-2008-6.
citation: Xue Y, Redeuil KM, Gimenez EC, Vinyes-Pares G, Zhao A, He T, Yang X, Zheng Y, Zhang Y, Wang P, Thakkar SK. Regional, socioeconomic, and dietary factors influencing B-vitamins in human milk of urban Chinese lactating women at different lactation stages. BMC Nutr. 2017 Mar 7;3:22. doi: 10.1186/s40795-017-0139-1. eCollection 2017.