Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
370 participants
OBSERVATIONAL
2012-12-31
2016-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breastfeeding mothers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Claude Billeaud, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Jean-Charles Picaud, Prof
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Croix-Rousse
Thameur Rakza, Dr
Role: PRINCIPAL_INVESTIGATOR
CHRU de Lille
Massimo Agosti, Dr
Role: PRINCIPAL_INVESTIGATOR
Ospedale del Ponte Varese
Tom Stiris, Dr
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Silva Gorett, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital de S. João Porto
Almerinda Barroso Pereira, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital de São Marcos - Braga
Maria Jose Costeira, Dr
Role: PRINCIPAL_INVESTIGATOR
Guimarães Hospital Braga
Isam Al-Jashi, Dr
Role: PRINCIPAL_INVESTIGATOR
Al Jashi Isam Private Med. Practice Bucharest
Sylvia Stoicescu, Dr
Role: PRINCIPAL_INVESTIGATOR
Polizu Hospital Bucharest
Cecilia Martinez-Costa, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Valencia
Magnus Domellöf,, Dr
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Mireille Vanpeé, Dr
Role: PRINCIPAL_INVESTIGATOR
Karolinska University hospital in Solna
Giovanna Marchini, Dr
Role: PRINCIPAL_INVESTIGATOR
Karolinska University hospital in Solna
Locations
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CHU Bordeaux
Bordeaux, , France
CHRU de Lille
Lille, , France
Hôpital de la Croix Rousse
Lyon, , France
Ospedale del Ponte
Varese, , Italy
Oslo University Hospital
Oslo, , Norway
Centro Hospitalar do Alto Ave Guimarães Hospital
Braga, , Portugal
Hospital de São Marcos
Braga, , Portugal
Hospital de S. João
Porto, , Portugal
Al Jashi Isam Private Med. Practice
Bucharest, , Romania
Polizu Hospital
Bucharest, , Romania
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Department of Woman and Child Health, Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Umeå University hospital
Umeå, , Sweden
Countries
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References
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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.
Other Identifiers
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11.33.NRC
Identifier Type: -
Identifier Source: org_study_id
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