<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/NCT03805997</url>
  </required_header>
  <id_info>
    <org_study_id>35RC17_8820</org_study_id>
    <nct_id>NCT03805997</nct_id>
  </id_info>
  <brief_title>Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?</brief_title>
  <acronym>ALLAITEMENT</acronym>
  <official_title>Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food&#xD;
      products that contain more ALA than conventional products, could impact nutritional and&#xD;
      non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the&#xD;
      implantation of the intestinal microbiota of the newborn, which is involved in preservation&#xD;
      of short term and long term health of the child.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 8, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of α-linolenic acid in milk</measure>
    <time_frame>on the 21st postpartum day.</time_frame>
    <description>The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The α-linolenic acid level of breast milk</measure>
    <time_frame>at the 45th postpartum day;</time_frame>
    <description>The α-linolenic acid level of breast milk at the 45th postpartum day;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The fatty acid content of breast milk ;</measure>
    <time_frame>on the 21st and the 45th postpartum days</time_frame>
    <description>The fatty acid content of breast milk on the 21st and the 45th postpartum days;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cytokine content of breast milk</measure>
    <time_frame>on the 21st and the 45th postpartum days</time_frame>
    <description>The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The immunoglobulin A and G content of breast milk</measure>
    <time_frame>on the 21st and the 45th postpartum days;</time_frame>
    <description>The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The lactoferrin content (antimicrobial factor) of breast milk</measure>
    <time_frame>on the 21st and the 45th postpartum days;</time_frame>
    <description>The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The hormone content of breast milk</measure>
    <time_frame>on the 21st and the 45th postpartum days</time_frame>
    <description>The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The oligosaccharide content of breast milk</measure>
    <time_frame>on the 21st and the 45th postpartum days</time_frame>
    <description>The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The breast milk microbiota content</measure>
    <time_frame>on the 21st and the 45th postpartum days</time_frame>
    <description>The breast milk microbiota content on the 21st and the 45th postpartum days;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the bacterial intestinal microbiota content from the feces of the newborn</measure>
    <time_frame>on the 21st postpartum day;</time_frame>
    <description>the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid content</measure>
    <time_frame>before the 7th month of pregnancy and on the 21st postpartum day.</time_frame>
    <description>the fatty acid content of the women red blood cells of the woman before the 7th month of pregnancy and on the 21st postpartum day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The breast milk lipidome</measure>
    <time_frame>on the 21st postpartum day</time_frame>
    <description>the breast milk lipidome on the 21st postpartum day: 26 lipid classes comprising more than 300 different lipid species (in addition to the total fatty acid analyses of breast milk, in order to make a complete description of the lipid species provided);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maternal milk metabolome</measure>
    <time_frame>On the 21st postpartum day</time_frame>
    <description>the maternal milk metabolome on the 21st postpartum day: metabolites, hormones and other signal molecules (this analysis complements the previous ones by producing a complete description of non-lipid metabolites in breast milk);</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Feeding</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dietary advice</intervention_name>
    <description>participants will benefit of dietary device 30-minute dietary advice carried out by a doctor at the University Hospital of Rennes, in order to provide nutritional advice adapted to pregnant women.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Consumption of Bleu-Blanc-Coeur products</intervention_name>
    <description>consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No consumption of Bleu-Blanc-Coeur products</intervention_name>
    <description>no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>the fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contact</intervention_name>
    <description>Participants of the group A will be contacted by phone,sms, mail by a technician every 15 days from 7th month of pregnancy to the 8th month of pregnancy and then every week from the 9th month of pregnancy to the 45th postpartum day (except the week of childbirth), in order to collect their consumption data of the delivered food products.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>food questionnaire</intervention_name>
    <description>Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>newborn faeces sample</intervention_name>
    <description>Newborn faeces sample will be collected at 21 Days post partum</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>breast milk sample</intervention_name>
    <description>Breast milk sample will be collected at 21 days and 45 days post partum</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women over 18;&#xD;
&#xD;
          -  ≤ 28th week of amenorrhea&#xD;
&#xD;
          -  having a project of exclusive breastfeeding until at least the 45th day postpartum;&#xD;
&#xD;
          -  BMI before pregnancy between 18.5 and 30.0;&#xD;
&#xD;
          -  consuming frequently dairy products, eggs, meat (pork, beef, poultry);&#xD;
&#xD;
          -  accepting the consumption of all food products delivered;&#xD;
&#xD;
          -  written consent received and signed.&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          -  multiple pregnancy;&#xD;
&#xD;
          -  eating disorders or suspicion (defined by SCOFF score);&#xD;
&#xD;
          -  vegetarian, vegan or flexitarian;&#xD;
&#xD;
          -  allergic to food product(s) involved in the study;&#xD;
&#xD;
          -  home with more than 2 adults and 3 children (excluding foetus);&#xD;
&#xD;
          -  adults on legal protection (guardianship, trusteeship…), persons deprived of liberty;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Interruption of breastfeeding before the 21st postpartum day&#xD;
&#xD;
          -  Prematurity: childbirth before the 37th week of amenorrhea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ronan Thibault</last_name>
    <phone>0299285405</phone>
    <phone_ext>+33</phone_ext>
    <email>ronan.thibault@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabrice Lainé</last_name>
    <phone>0299283715</phone>
    <phone_ext>+33</phone_ext>
    <email>fabrice.laine@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CIC CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronan Thibault</last_name>
      <phone>0299285405</phone>
      <email>ronan.thibault@chu-rennes.fr</email>
    </contact>
    <contact_backup>
      <last_name>Fabrice Laine</last_name>
      <phone>0299283715</phone>
      <phone_ext>+33</phone_ext>
      <email>fabrice.laine@chu-rennes.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03805997
org study id: 35RC17_8820
nct id: NCT03805997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food
      products that contain more ALA than conventional products, could impact nutritional and
      non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the
      implantation of the intestinal microbiota of the newborn, which is involved in preservation
      of short term and long term health of the child.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Level of α-linolenic acid in milk
time frame: on the 21st postpartum day.
description: The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.
measure: The α-linolenic acid level of breast milk
time frame: at the 45th postpartum day;
description: The α-linolenic acid level of breast milk at the 45th postpartum day;
measure: The fatty acid content of breast milk ;
time frame: on the 21st and the 45th postpartum days
description: The fatty acid content of breast milk on the 21st and the 45th postpartum days;
measure: The cytokine content of breast milk
time frame: on the 21st and the 45th postpartum days
description: The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ
measure: The immunoglobulin A and G content of breast milk
time frame: on the 21st and the 45th postpartum days;
description: The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days;
measure: The lactoferrin content (antimicrobial factor) of breast milk
time frame: on the 21st and the 45th postpartum days;
description: The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;
measure: The hormone content of breast milk
time frame: on the 21st and the 45th postpartum days
description: The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;
measure: The oligosaccharide content of breast milk
time frame: on the 21st and the 45th postpartum days
description: The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;
measure: The breast milk microbiota content
time frame: on the 21st and the 45th postpartum days
description: The breast milk microbiota content on the 21st and the 45th postpartum days;
measure: the bacterial intestinal microbiota content from the feces of the newborn
time frame: on the 21st postpartum day;
description: the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;
measure: Fatty acid content
time frame: before the 7th month of pregnancy and on the 21st postpartum day.
description: the fatty acid content of the women red blood cells of the woman before the 7th month of pregnancy and on the 21st postpartum day.
measure: The breast milk lipidome
time frame: on the 21st postpartum day
description: the breast milk lipidome on the 21st postpartum day: 26 lipid classes comprising more than 300 different lipid species (in addition to the total fatty acid analyses of breast milk, in order to make a complete description of the lipid species provided);
measure: The maternal milk metabolome
time frame: On the 21st postpartum day
description: the maternal milk metabolome on the 21st postpartum day: metabolites, hormones and other signal molecules (this analysis complements the previous ones by producing a complete description of non-lipid metabolites in breast milk);
arm group label: Experimental Group
arm group type: Experimental
description: consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
arm group label: Control Group
arm group type: Placebo Comparator
description: no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.
intervention type: Device
intervention name: Dietary advice
description: participants will benefit of dietary device 30-minute dietary advice carried out by a doctor at the University Hospital of Rennes, in order to provide nutritional advice adapted to pregnant women.
arm group label: Control Group
arm group label: Experimental Group
intervention type: Other
intervention name: Consumption of Bleu-Blanc-Coeur products
description: consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
arm group label: Experimental Group
intervention type: Other
intervention name: No consumption of Bleu-Blanc-Coeur products
description: no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.
arm group label: Control Group
intervention type: Biological
intervention name: Blood sample
description: the fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum
arm group label: Control Group
arm group label: Experimental Group
intervention type: Other
intervention name: Contact
description: Participants of the group A will be contacted by phone,sms, mail by a technician every 15 days from 7th month of pregnancy to the 8th month of pregnancy and then every week from the 9th month of pregnancy to the 45th postpartum day (except the week of childbirth), in order to collect their consumption data of the delivered food products.
arm group label: Experimental Group
intervention type: Other
intervention name: food questionnaire
description: Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
arm group label: Control Group
arm group label: Experimental Group
intervention type: Other
intervention name: newborn faeces sample
description: Newborn faeces sample will be collected at 21 Days post partum
arm group label: Control Group
arm group label: Experimental Group
intervention type: Other
intervention name: breast milk sample
description: Breast milk sample will be collected at 21 days and 45 days post partum
arm group label: Control Group
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ronan Thibault
phone: 0299285405
phone ext: +33
email: ronan.thibault@chu-rennes.fr
last name: Fabrice Lainé
phone: 0299283715
phone ext: +33
email: fabrice.laine@chu-rennes.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor