Atlas of Human Milk Nutrients

Breastfeeding Mothers Clinical Trial

Official title:

Atlas of Human Milk Nutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894893
• Other study ID #: 11.33.NRC
• Status: Completed
• Phase: N/A
• First received: April 25, 2013
• Last updated: January 4, 2016
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breastfeeding Mothers

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHRU de Lille	Lille
France	Hôpital de la Croix Rousse	Lyon
Italy	Ospedale del Ponte	Varese
Norway	Oslo University Hospital	Oslo
Portugal	Centro Hospitalar do Alto Ave Guimarães Hospital	Braga
Portugal	Hospital de São Marcos	Braga
Portugal	Hospital de S. João	Porto
Romania	Al Jashi Isam Private Med. Practice	Bucharest
Romania	Polizu Hospital	Bucharest
Spain	Hospital Clínico Universitario de Valencia	Valencia
Sweden	Department of Woman and Child Health, Karolinska University Hospital	Stockholm
Sweden	Umeå University hospital	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

France,  Italy,  Norway,  Portugal,  Romania,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of human milk components	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.	Between 0 and 4 months after delivery	No
Secondary	Human milk composition versus mothers' diet data	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.	between 3 months before delivery and 4 months after delivery	No
Secondary	Human milk composition versus maternal clinical parameters	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.	Between 0 and 4 months after delivery	No
Secondary	Human milk composition versus mother and infant clinical parameters	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.	Between 0 and 4 months after delivery	No