Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia

Sponsor
University of Santiago de Compostela (Other)
Overall Status
Completed
CT.gov ID
NCT03245697
Collaborator
(none)
102
37.4

Study Details

Study Description

Brief Summary

Human milk is not a uniform body fluid, but quite the opposite, its composition changes continuously adapting to the requirements of the newborn. It can be considered as the gold standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during the first months of life. Additionally, its composition should be used as reference or guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In that connection, the nutritional status and dietary habits/patterns of the mother, along with certain genetic traits, exert also influence over breast milk. Considering all these facts, and their great impact on (present and future) infant health, detailed information of breast milk composition is required for specific populations, covering as many factors, elements and nutrients as possible.

In the present observational study, research is focused on breast milk in northwestern Spain, more precisely Galicia. In this context, the obtained data will serve to define the nutritional characteristics of breast milk from Galician women (interindividual variation), while at the same time evaluating the existence of specific features related to their particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the variables measured in this research project will be related with breast milk composition. Expected primary outcomes can be divided as follows: fatty acid profiles, mineral composition, essential amino acid profiles, microbiota and steroid hormones. The key influencing factors taken into account are: lactation characteristics and maternal diet.

Recruitment of participants is based on all the following criteria, with no exceptions:

female, living in Galicia, lactating, > 18 years old, volunteer participation, written informed consent and agreement to complete questionnaires about lactation, diet and other socio-demographic factors. Samples are collected by participants, and stored at the University of Santiago de Compostela under a coded system so that it is impossible to identify the donor from whom the sample comes, with the exception of the investigators. The project is adhered to the principles of the Helsinki Declaration. Participants are allowed to withdraw their consent at any moment of the study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    102 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia
    Actual Study Start Date :
    Jul 19, 2016
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Sep 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Lactating mothers

    Lactating mothers recruited in Galicia (NW Spain)

    Outcome Measures

    Primary Outcome Measures

    1. Fatty acid profile of breast milk in Galicia [2016]

      Fatty acid profile of breast milk collected from lactating women in Galicia, at different points postpartum; discussion on diet influence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • female

    • lactating

    • living in Galicia

    • voluntary participation

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Santiago de Compostela

    Investigators

    • Principal Investigator: PATRICIA REGAL, PhD, University of Santiago de Compostela

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PATRICIA REGAL, Professor and PhD researcher, University of Santiago de Compostela
    ClinicalTrials.gov Identifier:
    NCT03245697
    Other Study ID Numbers:
    • 2016-CL045
    First Posted:
    Aug 10, 2017
    Last Update Posted:
    Mar 26, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PATRICIA REGAL, Professor and PhD researcher, University of Santiago de Compostela

    Study Results

    No Results Posted as of Mar 26, 2020