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

NCT01971671 | Completed

• 1 other identifier: 11.14.NRC
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

To understand breast milk composition during different lactating stages.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Other nutrient composition in breast milk of 0-270 days after delivery.

  0-270 days after delivery.

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

  0-270 days after delivery.

• Nutrients intake and adequacy of lactating mothers of 0-270 days after delivery.

  0-270 days after delivery

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

  0-270 days after delivery.

Study Arms (1)

Chinese lactating mother

no intervention.

Other: no intervention.

Interventions

no intervention. OTHER

Chinese lactating mother

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Health Science Center, Peking University

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 32153804 DERIVED

• 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.

  PMID: 30227842 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

breask milk sample.

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 29, 2013
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

CN (1)