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Completed

NCT Number: NCT01894893

Atlas of Human Milk Nutrients

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

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Key information

Conditions

Breastfeeding Mothers

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2013
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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