Atlas of Human Milk Nutrients

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

Study Overview

• Status: Completed
• Conditions: Breastfeeding Mothers

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux
  • Lille, France
    • CHRU de Lille
  • Lyon, France
    • Hôpital de la Croix Rousse
• Italy
  • Varese, Italy
    • Ospedale Del Ponte
• Norway
  • Oslo, Norway
    • Oslo University Hospital
• Portugal
  • Braga, Portugal
    • Centro Hospitalar do Alto Ave Guimarães Hospital
  • Braga, Portugal
    • Hospital de São Marcos
  • Porto, Portugal
    • Hospital de S. João
• Romania
  • Bucharest, Romania
    • Al Jashi Isam Private Med. Practice
  • Bucharest, Romania
    • Polizu Hospital
• Spain
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia
• Sweden
  • Stockholm, Sweden, 171 76
    • Department of Woman and Child Health, Karolinska University Hospital
  • Umea, Sweden
    • Umea University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy mothers of any ethnicity having decided to exclusively breast-feed their new born baby from birth up to 4 months of age will be eligible to participate in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Breastfeeding mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Claude Billeaud, Prof, CHU Bordeaux; Principal Investigator: Jean-Charles Picaud, Prof, Hôpital de la Croix-Rousse; Principal Investigator: Thameur Rakza, Dr, CHRU de Lille; Principal Investigator: Massimo Agosti, Dr, Ospedale del Ponte Varese; Principal Investigator: Tom Stiris, Dr, Oslo University Hospital; Principal Investigator: Silva Gorett, Dr, Hospital de S. João Porto; Principal Investigator: Almerinda Barroso Pereira, Dr, Hospital de São Marcos - Braga; Principal Investigator: Maria Jose Costeira, Dr, Guimarães Hospital Braga; Principal Investigator: Isam Al-Jashi, Dr, Al Jashi Isam Private Med. Practice Bucharest; Principal Investigator: Sylvia Stoicescu, Dr, Polizu Hospital Bucharest; Principal Investigator: Cecilia Martinez-Costa, Dr, Hospital Clinico Universitario de Valencia; Principal Investigator: Magnus Domellöf,, Dr, Umeå University; Principal Investigator: Mireille Vanpeé, Dr, Karolinska University Hospital in Solna; Principal Investigator: Giovanna Marchini, Dr, Karolinska University Hospital in Solna

Publications and helpful links

General Publications

• Raymond F, Lefebvre G, Texari L, Pruvost S, Metairon S, Cottenet G, Zollinger A, Mateescu B, Billeaud C, Picaud JC, Silva-Zolezzi I, Descombes P, Bosco N. Longitudinal Human Milk miRNA Composition over the First 3 mo of Lactation in a Cohort of Healthy Mothers Delivering Term Infants. J Nutr. 2022 Jan 11;152(1):94-106. doi: 10.1093/jn/nxab282.
• Binia A, Lavalle L, Chen C, Austin S, Agosti M, Al-Jashi I, Pereira AB, Costeira MJ, Silva MG, Marchini G, Martinez-Costa C, Stiris T, Stoicescu SM, Vanpee M, Rakza T, Billeaud C, Picaud JC, Domellof M, Adams R, Castaneda-Gutierrez E, Sprenger N. Human milk oligosaccharides, infant growth, and adiposity over the first 4 months of lactation. Pediatr Res. 2021 Sep;90(3):684-693. doi: 10.1038/s41390-020-01328-y. Epub 2021 Jan 14.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: July 4, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 11.33.NRC