Breastfeeding MothersNCT01894893
Atlas of Human Milk Nutrients
An observational study of Breastfeeding Mothers, run by Société des Produits Nestlé (SPN) at 13 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Mothers
- How many people
- 370 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Dec 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
France3 sites
CHU Bordeaux
Bordeaux
CHRU de Lille
Lille
Hôpital de la Croix Rousse
Lyon
Portugal3 sites
Centro Hospitalar do Alto Ave Guimarães Hospital
Braga
Hospital de São Marcos
Braga
Hospital de S. João
Porto
Romania2 sites
Al Jashi Isam Private Med. Practice
Bucharest
Polizu Hospital
Bucharest
Sweden2 sites
Department of Woman and Child Health, Karolinska University Hospital
Stockholm, Stockholm County, 171 76
Umeå University hospital
Umeå
About this study
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:
- To assess whether there is a correlation between human milk composition and mothers' diet
- To assess whether there is a correlation between human milk composition and maternal clinical parameters
- To assess whether there is a correlation between human milk composition and mother and infant clinical parameters
- Conditions
- Breastfeeding Mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding mothers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 0 and 4 months after delivery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Between 0 and 4 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding MothersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Billeaud, Prof, Principal investigator, University Hospital, BordeauxJean-Charles Picaud, Prof, Principal investigator, Hôpital de la Croix-RousseThameur Rakza, Dr, Principal investigator, CHRU de LilleMassimo Agosti, Dr, Principal investigator, Ospedale del Ponte VareseTom Stiris, Dr, Principal investigator, Oslo University HospitalSilva Gorett, Dr, Principal investigator, Hospital de S. João PortoAlmerinda Barroso Pereira, Dr, Principal investigator, Hospital de São Marcos - BragaMaria Jose Costeira, Dr, Principal investigator, Guimarães Hospital Braga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894893
- Sponsor's protocol ID
- 11.33.NRC
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34510208Binia 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.
PubMed 33446921
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atlas of Human Milk Nutrients
- ClinicalTrials.gov ID
- NCT01894893
- Acronym / sponsor ID
- 11.33.NRC
- Conditions
- Breastfeeding Mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess whether there is a correlation between human milk composition and mothers' diet
- To assess whether there is a correlation between human milk composition and maternal clinical parameters
- To assess whether there is a correlation between human milk composition and mother and infant clinical parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding mothers | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Human milk composition versus mothers' diet data
Time frame: between 3 months before delivery and 4 months after delivery
Human milk composition versus maternal clinical parameters
Time frame: Between 0 and 4 months after delivery
Human milk composition versus mother and infant clinical parameters
Time frame: Between 0 and 4 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Derived from this study: PubMed 34510208Raymond 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.
- Derived from this study: PubMed 33446921Binia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Billeaud, Prof principal investigator
University Hospital, Bordeaux
Jean-Charles Picaud, Prof principal investigator
Hôpital de la Croix-Rousse
Thameur Rakza, Dr principal investigator
CHRU de Lille
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding Mothers, run by Société des Produits Nestlé (SPN) at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Portugal, Romania, Sweden, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of human milk components (time frame: Between 0 and 4 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.