xml: <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/NCT06018259</url>
    </required_header>
    <id_info>
      <org_study_id>LIP-PBMC</org_study_id>
      <nct_id>NCT06018259</nct_id>
    </id_info>
    <brief_title>Bioactive Lipids &amp; PBMC</brief_title>
    <official_title>Investigations on the Role of Bioactive Lipids in the Control of PBMC Activation and Differentiation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université Catholique de Louvain</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Université Catholique de Louvain</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>
        The investigators aim at harvesting PBMC from healthy donors to study the effect of the&#xD;
        lipids mediators of interest. After isolation from the blood, PBMC will be activated as&#xD;
        largely reported in the literature in the presence or absence of the tested lipids. The&#xD;
        effect will be assessed by quantifying the expression of inflammatory markers. The expression&#xD;
        of the receptors and enzymes potentially regulating the effects of the studied lipids will&#xD;
        also be assessed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data from the scientific literature support the hypothesis that bioactive lipids play an&#xD;
        important role in inflammatory disorders. The levels of these bioactive lipids are altered in&#xD;
        several pathophysiological conditions with an inflammatory component. The investigators and&#xD;
        others have demonstrated that bioactive lipids affect the inflammatory tone in vivo in murine&#xD;
        models as well as in in vitro models. However, confirming the translational value of these&#xD;
        data is not easy in clinical studies. PBMC-based experiments are a powerful tool for us to&#xD;
        validate our previous observations and will offer translational added value supporting&#xD;
        further clinical investigations.&#xD;
  &#xD;
        Thus, here the investigators aim at harvesting PBMC from healthy donors and use them to study&#xD;
        the effect of the lipid mediators of interest (i.e. those showing interesting properties in&#xD;
        our preclinical models). Blood will be collected from healthy volunteers, and PMBC isolated&#xD;
        based on their density. After isolation from the blood, PBMC will be activated as largely&#xD;
        reported in the literature (e.g. using phytohemagglutinin or lipopolysaccharides) in the&#xD;
        presence or absence of the tested lipids. The effect will be assessed by quantifying the&#xD;
        expression of inflammatory markers (by RT-qPCR and/or ELISA). The expression of the receptors&#xD;
        and enzymes potentially regulating the effects of the studied lipids will be also assessed&#xD;
        (by RT-qPCR).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 2030</completion_date>
    <primary_completion_date type="Anticipated">May 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in PBMC proliferation, differentiation or activation</measure>
      <time_frame>Throughout the study, an average of 5,5 years</time_frame>
      <description>Expression of inflammatory markers (e.g. cytokines: IL-1, IL-6,...), by RT-qPCR and/or ELISA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between the expression of enzymes or receptors and the PBMC activation state</measure>
      <time_frame>Throughout the study, an average of 5,5 years</time_frame>
      <description>Expression of the receptors known to mediate the effects of the lipids studied</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>healthy volunteers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>healthy volunteers blood sampling</intervention_name>
      <description>One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them PBMC will be activated in vitro (e.g. using LPS or PHA) in the presence or absence of the lipid of interest.</description>
      <arm_group_label>healthy volunteers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteers must be able to give informed consent to be included in the study.&#xD;
  &#xD;
            -  no chronic inflammatory disease&#xD;
  &#xD;
            -  no acute inflammation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Men and women aged less than 18 years&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Prior diagnosis of a chronic inflammatory disease (for instance IBD, COPD, lupus, MS,&#xD;
               etc. This is not an exhaustive list).&#xD;
  &#xD;
            -  Recent (&lt;21 days) episode of acute inflammation or immune-altering event (e.g. cold,&#xD;
               flu, vaccine, …).&#xD;
  &#xD;
            -  Chronic or recent use of drugs interfering with the immune / inflammatory response.&#xD;
               Examples include (and are not limited to) NSAIDs, corticosteroids, aspirin, mABs, etc.&#xD;
  &#xD;
            -  Unable to give informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Giulio Muccioli, prof</last_name>
      <role>Study Director</role>
      <affiliation>Université Catholique de Louvain</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Giulio Muccioli, prof</last_name>
      <email>giulio.muccioli@uclouvain.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mireille Al Houayek, PhD</last_name>
      <email>mireille.alhouayek@uclouvain.be</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>inflammation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018259
  org study id: LIP-PBMC
  nct id: NCT06018259
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aim at harvesting PBMC from healthy donors to study the effect of the
        lipids mediators of interest. After isolation from the blood, PBMC will be activated as
        largely reported in the literature in the presence or absence of the tested lipids. The
        effect will be assessed by quantifying the expression of inflammatory markers. The expression
        of the receptors and enzymes potentially regulating the effects of the studied lipids will
        also be assessed.
  Data from the scientific literature support the hypothesis that bioactive lipids play an
        important role in inflammatory disorders. The levels of these bioactive lipids are altered in
        several pathophysiological conditions with an inflammatory component. The investigators and
        others have demonstrated that bioactive lipids affect the inflammatory tone in vivo in murine
        models as well as in in vitro models. However, confirming the translational value of these
        data is not easy in clinical studies. PBMC-based experiments are a powerful tool for us to
        validate our previous observations and will offer translational added value supporting
        further clinical investigations.
  
        Thus, here the investigators aim at harvesting PBMC from healthy donors and use them to study
        the effect of the lipid mediators of interest (i.e. those showing interesting properties in
        our preclinical models). Blood will be collected from healthy volunteers, and PMBC isolated
        based on their density. After isolation from the blood, PBMC will be activated as largely
        reported in the literature (e.g. using phytohemagglutinin or lipopolysaccharides) in the
        presence or absence of the tested lipids. The effect will be assessed by quantifying the
        expression of inflammatory markers (by RT-qPCR and/or ELISA). The expression of the receptors
        and enzymes potentially regulating the effects of the studied lipids will be also assessed
        (by RT-qPCR).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in PBMC proliferation, differentiation or activation
  time frame: Throughout the study, an average of 5,5 years
  description: Expression of inflammatory markers (e.g. cytokines: IL-1, IL-6,...), by RT-qPCR and/or ELISA
  measure: Correlation between the expression of enzymes or receptors and the PBMC activation state
  time frame: Throughout the study, an average of 5,5 years
  description: Expression of the receptors known to mediate the effects of the lipids studied
  arm group label: healthy volunteers
  arm group type: Experimental
  description: One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them
  intervention type: Procedure
  intervention name: healthy volunteers blood sampling
  description: One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them PBMC will be activated in vitro (e.g. using LPS or PHA) in the presence or absence of the lipid of interest.
  arm group label: healthy volunteers
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Giulio Muccioli, prof
  role: Study Director
  affiliation: Université Catholique de Louvain
  last name: Giulio Muccioli, prof
  email: giulio.muccioli@uclouvain.be
  last name: Mireille Al Houayek, PhD
  email: mireille.alhouayek@uclouvain.be
  responsible party type: Sponsor
  sharing ipd: No