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Atlas of Human Milk Nutrients

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ClinicalTrials.gov Identifier: NCT01894893
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease
Breastfeeding Mothers

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Study Type : Observational
Actual Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atlas of Human Milk Nutrients
Study Start Date : December 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Group/Cohort
Breastfeeding mothers



Primary Outcome Measures :
  1. Characterization of human milk components [ Time Frame: 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 :
  1. Human milk composition versus mothers' diet data [ Time Frame: 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.

  2. Human milk composition versus maternal clinical parameters [ Time Frame: 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.

  3. Human milk composition versus mother and infant clinical parameters [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
  1. Mother milk
  2. Umbilical cord blood
  3. Mother blood
  4. Adipose tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894893


Locations
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France
CHU Bordeaux
Bordeaux, France
CHRU de Lille
Lille, France
Hôpital de la Croix Rousse
Lyon, France
Italy
Ospedale del Ponte
Varese, Italy
Norway
Oslo University Hospital
Oslo, Norway
Portugal
Centro Hospitalar do Alto Ave Guimarães Hospital
Braga, Portugal
Hospital de São Marcos
Braga, Portugal
Hospital de S. João
Porto, Portugal
Romania
Al Jashi Isam Private Med. Practice
Bucharest, Romania
Polizu Hospital
Bucharest, Romania
Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Sweden
Department of Woman and Child Health, Karolinska University Hospital
Stockholm, Sweden, 171 76
Umeå University hospital
Umea, Sweden
Sponsors and Collaborators
Nestlé
Investigators
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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 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
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01894893    
Other Study ID Numbers: 11.33.NRC
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016