Atlas of Human Milk Nutrients

NCT01894893 | Completed

• 1 other identifier: 11.33.NRC
• Study Type: observational
• Target: 370
• Locations: 7 countries
• Sites: 13

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. 1.To assess whether there is a correlation between human milk composition and mothers' diet
2. 2.To assess whether there is a correlation between human milk composition and maternal clinical parameters
3. 3.To assess whether there is a correlation between human milk composition and mother and infant clinical parameters

Conditions

Breastfeeding Mothers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Human milk composition versus mothers' diet data

  between 3 months before delivery and 4 months after delivery

• Human milk composition versus maternal clinical parameters

  Between 0 and 4 months after delivery

• Human milk composition versus mother and infant clinical parameters

  Between 0 and 4 months after delivery

Study Arms (1)

Breastfeeding mothers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (13)

CHU Bordeaux

Bordeaux, France

Location

CHRU de Lille

Lille, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Ospedale del Ponte

Varese, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

Centro Hospitalar do Alto Ave Guimarães Hospital

Braga, Portugal

Location

Hospital de São Marcos

Braga, Portugal

Location

Hospital de S. João

Porto, Portugal

Location

Al Jashi Isam Private Med. Practice

Bucharest, Romania

Location

Polizu Hospital

Bucharest, Romania

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Department of Woman and Child Health, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location

Umeå University hospital

Umeå, Sweden

Location

Related Publications (2)

• 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.

  PMID: 34510208 DERIVED

• 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.

  PMID: 33446921 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Mother milk 2. Umbilical cord blood 3. Mother blood 4. Adipose tissue

Study Officials

• Claude Billeaud, Prof

  University Hospital, 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 Clínico 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: July 10, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

SE (2); IT (1); PT (3); RO (2); ES (1); FR (3); NO (1)