Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai (MuRu)

This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.

Study Overview

• Status: Unknown
• Conditions: Breast Milk

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

General health lactating mothers

Description

Inclusion Criteria:

• Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is >10 and <90 percentiles gestational birth weight chart.
• Aged 20 - 40 years.
• Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
• Chinese ethnicity, including both parents.
• Mothers who sign the informed consent form in writing.

Exclusion Criteria:

Mothers:

• Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
• Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
• Current smoker or having smoked during the pregnancy.
• Having consumed alcoholic drinks during pregnancy or lactation.
• Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
• Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
• Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
• Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
• Presence of endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
• Presence of obesity (pre-pregnancy BMI > 28).
• Presence of chronic diseases such as cardiovascular, renal, respiratory and hepatic diseases.
• Presence of psychosis and severe post-partum depression.
• Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
• Women whose health condition, according to the investigator's judgement, could interfere with the study conduct and assessment.
• Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
• Elimination diet due to chronic allergic diseases or vegan.
• Incapability of subject to comply with study protocol or investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.

Infants:

• Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Community Group; Chinese lactating mothers from community maternal & child healthcare centre
VIP Group; Chinese lactating mothers from VIP clinics (maternal care center)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast milk composition	Human milk oligosaccharides profiles, fatty acids profile, macronutrients and energy content will be measured.	0-42 day postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Infant's anthropometrics (weight, length, head circumference).	0-42 day postpartum
Maternal diet survey	Dietary macronutrients and energy intake, and food patterns will be assessed.	0-42 day postpartum
Infection	Parent-reported infection patterns of infants during the observation period.	0-42 day postpartum

Collaborators and Investigators

• Sponsor: Dumex Baby Food Co., Ltd.
• Collaborators: Shanghai Children's Medical Center
• Investigators: Principal Investigator: Jing Li, professor, Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University, School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: February 23, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: breast milk, dietary survey
• Other Study ID Numbers: HMR.1.C/A