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

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

To understand breast milk composition during different lactating stages.

Study Overview

• Status: Completed
• Conditions: Focus of Study is Healthy Chinese Lactating Mother 0-270 Days
• Intervention / Treatment: Other: no intervention.

• Study Type: Observational
• Enrollment (Actual): 560

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Health Science Center, Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy Chinese lactating mother 0-270 days after delivery (inclusive) will be enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese lactating mother; no intervention.	Other: no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-270 days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	0-270 days after delivery.

Collaborators and Investigators

• Sponsor: Nestlé

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 11.14.NRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No