Atlas of Human Milk Nutrients

January 4, 2016 updated by: Nestlé

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Clínico Universitario de Valencia
  • Sweden
      • Stockholm, Sweden, 171 76
        • Department of Woman and Child Health, Karolinska University Hospital
      • Umea, Sweden
        • Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Breastfeeding mothers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Between 0 and 4 months after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
Between 0 and 4 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11.33.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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