<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03245697</url>
  </required_header>
  <id_info>
    <org_study_id>2016-CL045</org_study_id>
    <nct_id>NCT03245697</nct_id>
  </id_info>
  <brief_title>Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia</brief_title>
  <official_title>Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Santiago de Compostela</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Santiago de Compostela</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human milk is not a uniform body fluid, but quite the opposite, its composition changes&#xD;
      continuously adapting to the requirements of the newborn. It can be considered as the gold&#xD;
      standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during&#xD;
      the first months of life. Additionally, its composition should be used as reference or&#xD;
      guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In&#xD;
      that connection, the nutritional status and dietary habits/patterns of the mother, along with&#xD;
      certain genetic traits, exert also influence over breast milk. Considering all these facts,&#xD;
      and their great impact on (present and future) infant health, detailed information of breast&#xD;
      milk composition is required for specific populations, covering as many factors, elements and&#xD;
      nutrients as possible.&#xD;
&#xD;
      In the present observational study, research is focused on breast milk in northwestern Spain,&#xD;
      more precisely Galicia. In this context, the obtained data will serve to define the&#xD;
      nutritional characteristics of breast milk from Galician women (interindividual variation),&#xD;
      while at the same time evaluating the existence of specific features related to their&#xD;
      particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the&#xD;
      variables measured in this research project will be related with breast milk composition.&#xD;
      Expected primary outcomes can be divided as follows: fatty acid profiles, mineral&#xD;
      composition, essential amino acid profiles, microbiota and steroid hormones. The key&#xD;
      influencing factors taken into account are: lactation characteristics and maternal diet.&#xD;
&#xD;
      Recruitment of participants is based on all the following criteria, with no exceptions:&#xD;
      female, living in Galicia, lactating, &gt; 18 years old, volunteer participation, written&#xD;
      informed consent and agreement to complete questionnaires about lactation, diet and other&#xD;
      socio-demographic factors. Samples are collected by participants, and stored at the&#xD;
      University of Santiago de Compostela under a coded system so that it is impossible to&#xD;
      identify the donor from whom the sample comes, with the exception of the investigators. The&#xD;
      project is adhered to the principles of the Helsinki Declaration. Participants are allowed to&#xD;
      withdraw their consent at any moment of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatty acid profile of breast milk in Galicia</measure>
    <time_frame>2016</time_frame>
    <description>Fatty acid profile of breast milk collected from lactating women in Galicia, at different points postpartum; discussion on diet influence.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Milk, Human</condition>
  <arm_group>
    <arm_group_label>Lactating mothers</arm_group_label>
    <description>Lactating mothers recruited in Galicia (NW Spain)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Lactating/nursing women living in northwestern Spain (Galicia)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  lactating&#xD;
&#xD;
          -  living in Galicia&#xD;
&#xD;
          -  voluntary participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Lactating mothers</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>PATRICIA REGAL, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Santiago de Compostela</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Santiago de Compostela</investigator_affiliation>
    <investigator_full_name>PATRICIA REGAL</investigator_full_name>
    <investigator_title>Professor and PhD researcher</investigator_title>
  </responsible_party>
  <keyword>breast milk</keyword>
  <keyword>composition</keyword>
  <keyword>Galicia</keyword>
  <keyword>diet</keyword>
  <keyword>lactation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245697
org study id: 2016-CL045
nct id: NCT03245697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Fatty acid profile of breast milk in Galicia
time frame: 2016
description: Fatty acid profile of breast milk collected from lactating women in Galicia, at different points postpartum; discussion on diet influence.
arm group label: Lactating mothers
description: Lactating mothers recruited in Galicia (NW Spain)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Lactating mothers
minimum age: 18 Years
maximum age: N/A
last name: PATRICIA REGAL, PhD
role: Principal Investigator
affiliation: University of Santiago de Compostela
responsible party type: Principal Investigator
investigator affiliation: University of Santiago de Compostela
investigator full name: PATRICIA REGAL
investigator title: Professor and PhD researcher
sharing ipd: Undecided