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

NCT02070562 | Unknown

• 1 other identifier: HMR.1.C/A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Milk

Keywords

breast milk, dietary survey

Outcome Measures

Primary Outcomes (1)

• Breast milk composition

  Human milk oligosaccharides profiles, fatty acids profile, macronutrients and energy content will be measured.

  0-42 day postpartum

Secondary Outcomes (3)

• Growth

  0-42 day postpartum

• Maternal diet survey

  0-42 day postpartum

• Infection

  0-42 day postpartum

Study Arms (2)

Community Group

Chinese lactating mothers from community maternal \& child healthcare centre

VIP Group

Chinese lactating mothers from VIP clinics (maternal care center)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

General health lactating mothers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dumex Baby Food Co., Ltd.: lead
• Shanghai Children's Medical Center: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

breast milk from 0-42 days postpartum

Study Officials

• Jing Li, professor

  Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

CN (1)