Atlas of Human Milk Nutrients

Completed

• Conditions: Breastfeeding Mothers

• Registration Number: NCT01894893
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:

1. To assess whether there is a correlation between human milk composition and mothers' diet

2. To assess whether there is a correlation between human milk composition and maternal clinical parameters

3. To assess whether there is a correlation between human milk composition and mother and infant clinical parameters

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 370

Inclusion Criteria

• Between 18 and 40 years of age included at time of enrolment
• BMI before pregnancy between 19 and 29 included
• Having signed the Informed Consent Form
• Having decided to exclusively breast-feed until infant is 4 months old

Exclusion Criteria

• Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
• Presenting any disease or medical condition which might prevent breast-feeding or collection the human milk samples or for which breast-feeding is not indicated
• Presenting diseases/medical conditions such as diabetes, heart problems, abnormal conditions of pregnancy (ex. hypertension)
• Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
• Assuming any medication indicated for the treatment of any metabolic or cardiovascular disease
• Cannot be expected to comply with the study procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of human milk components	Between 0 and 4 months after delivery	Nutrients in human breast milk samples will be characterized and quantified by analysing with modern analytical techniques (NMR, HPLC-MS and GC-MS) the human milk samples collected at each study visits (3d, 14 days, 1m, 2m, 3m and 4 months after delivery, 1 week after delivery, ). The parameters which will be assessed in human milk samples are : Total Energy Value, Total Macronutrients (lipids, proteins, carbohydrates, solids), Lipids' characterization, Peptide profiling, Oligosaccharides profiling, and Micro-RNA profiling. It will be done in 240 completed mothers.

Secondary Outcome Measures

Name	Time	Method
Human milk composition versus mothers' diet data	between 3 months before delivery and 4 months after delivery	The human milk composition profiles (primary outcome) will be correlated in a longitudinal manner to mothers' diet. Information on mother's diet will be collected using a 3-days diary and entering the data in Nutrilog (total intake of the mothers). This will be done before each study visit in 240 completed mothers.
Human milk composition versus maternal clinical parameters	Between 0 and 4 months after delivery	The human milk composition profiles will be correlated in a longitudinal manner to the stage of lactation, the gestation's age, the type of delivery, the sex of the baby, the number of babies the mother already had (gravidity and parity), single/multiple birth. It will be done in 240 completed mothers.
Human milk composition versus mother and infant clinical parameters	Between 0 and 4 months after delivery	The human milk composition profiles will be correlated in a longitudinal manner to infant anthropometric measurements (weight, height and head circumference). It will be done in 240 completed mothers.

Trial Locations

Locations (13)

CHRU de Lille; 🇫🇷 Lille, France

Centro Hospitalar do Alto Ave Guimarães Hospital; 🇵🇹 Braga, Portugal

Oslo University Hospital; 🇳🇴 Oslo, Norway

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hospital de São Marcos; 🇵🇹 Braga, Portugal

Hospital de S. João; 🇵🇹 Porto, Portugal

Ospedale del Ponte; 🇮🇹 Varese, Italy

Polizu Hospital; 🇷🇴 Bucharest, Romania

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Department of Woman and Child Health, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Umeå University hospital; 🇸🇪 Umea, Sweden

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Al Jashi Isam Private Med. Practice; 🇷🇴 Bucharest, Romania