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/NCT06041867</url>
    </required_header>
    <id_info>
      <org_study_id>METC 23-026</org_study_id>
      <nct_id>NCT06041867</nct_id>
    </id_info>
    <brief_title>Agaricus Bisporus and Influenza Vaccination Response</brief_title>
    <official_title>Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Scelta Mycofriends B.V.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CNC Grondstoffen B.V.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Maastricht University Medical Center</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>
        There are numerous in vitro and animal studies that suggested that mushrooms beneficially&#xD;
        influence the immune system. We have recently shown that a wild isolate of the edible&#xD;
        Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of&#xD;
        the immune system, both in vitro and in vivo in animals. The question now is whether this&#xD;
        efficacy can also be translated to humans. In humans, measuring the antibody response is the&#xD;
        golden standard to evaluate immune function. If Agaricus bisporus powder indeed has&#xD;
        beneficial effects on the immune system, people with overweight or obesity and higher age&#xD;
        might benefit from consuming Agaricus bisporus powder prior to receiving the influenza&#xD;
        vaccination.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 22, 2023</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vaccine specific antibody titer</measure>
      <time_frame>Maximal change form T=0 (change T=0 to T=3 weeks or T=4 weeks)</time_frame>
      <description>The response to the Influenza vaccine will be measured by quantifying the specific antibody titer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immune parameters (1)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immune parameters (2)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>hsCRP</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leukocyte count</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Number of leukocytes measured in EDTA plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leukocyte differential count</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Number of subgroups of leukocytes measured in EDTA plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (1)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Serum non-cholesterol sterols and stanols</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (2)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Serum lipid and lipoprotein profile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (3)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Plasma glucose</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (4)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Ergothioneine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (5)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Glutathione</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasted metabolism (6)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Malondialdehyde</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry (1)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)</time_frame>
      <description>Body weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry (2)</measure>
      <time_frame>Day -1 (start study)</time_frame>
      <description>Height</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry (3)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)</time_frame>
      <description>Waist circumference</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry (4)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)</time_frame>
      <description>Hip circumference</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry (5)</measure>
      <time_frame>Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)</time_frame>
      <description>Waist-to-hip ratio</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diet</measure>
      <time_frame>Day - 1 (start study), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume mushrooms outside the intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life questionnaire</measure>
      <time_frame>Day - 1 (start study), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diary outcomes (1)</measure>
      <time_frame>Day - 1 (start study), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Adverse events as assessed by the diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diary outcomes (2)</measure>
      <time_frame>Day - 1 (start study), T=4 weeks after vaccination (end of study)</time_frame>
      <description>Medication intake as assessed by the diary</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Immune Response</condition>
    <arm_group>
      <arm_group_label>Agaricus bisporus group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Influenza vaccine</intervention_name>
      <description>Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine</description>
      <arm_group_label>Agaricus bisporus group</arm_group_label>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Agaricus bisporus capsules</intervention_name>
      <description>Participants have to consume 10 capsules per day containing 500 mg Agaricus bisporus powder each, corresponding to a total Agariicus bisporus powder intake of 5 g daily</description>
      <arm_group_label>Agaricus bisporus group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Control capsules</intervention_name>
      <description>Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 60 years or older during influenza season 2023/2024 (in line with RIVM&#xD;
               guidelines)&#xD;
  &#xD;
            -  BMI between 20 and 35 kg/m2&#xD;
  &#xD;
            -  Willing to abstain from mushrooms other than the capsules containing a mushroom powder&#xD;
               as provided by us during the study period.&#xD;
  &#xD;
            -  Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplements&#xD;
               constant&#xD;
  &#xD;
            -  Willing to abstain from products / supplements enriched with Vitamin D&#xD;
  &#xD;
            -  Willing to abstain from products / supplements enriched with plant sterols or stanols&#xD;
  &#xD;
            -  Willing to abstain from products / supplements enriched with (β)glucans or fungi.&#xD;
  &#xD;
            -  Willing to abstain from products / supplements that are mentioned to &quot;boost your&#xD;
               immune system&quot;&#xD;
  &#xD;
            -  Willing to abstain from (products enriched in) pre/pro-biotics&#xD;
  &#xD;
            -  Willing to abstain from products/supplements enriched with ergothioneine&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Already received influenza vaccination in 2023&#xD;
  &#xD;
            -  Allergy to mushrooms&#xD;
  &#xD;
            -  Known allergic reaction to an active component or other components of the vaccine&#xD;
               (e.g. Chicken Eggs)&#xD;
  &#xD;
            -  Having donated blood within one month prior to the start of the study, or planning to&#xD;
               donate blood during the study&#xD;
  &#xD;
            -  Excessive alcohol use (&gt;20 consumptions per week)&#xD;
  &#xD;
            -  Regular use of soft and/or hard drugs&#xD;
  &#xD;
            -  Using medication for diseases known to affect inflammation/immunity (e.g. inhaled&#xD;
               corticosteroids and prednisone)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>59 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Maastricht University Medical Center</name>
        <address>
          <city>Maastricht</city>
          <state>Limburg</state>
          <zip>6229 ER</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Willem Zwaan, MSc</last_name>
        <phone>+31 88 388 7283</phone>
        <email>w.zwaan@maastrichtuniversity.nl</email>
      </contact>
      <investigator>
        <last_name>Jogchum Plat, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Agaricus bisporus</keyword>
    <keyword>Immune system</keyword>
    <keyword>Influenza vaccination</keyword>
    <keyword>Mushroom</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <!-- 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/NCT06041867
  org study id: METC 23-026
  nct id: NCT06041867
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There are numerous in vitro and animal studies that suggested that mushrooms beneficially
        influence the immune system. We have recently shown that a wild isolate of the edible
        Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of
        the immune system, both in vitro and in vivo in animals. The question now is whether this
        efficacy can also be translated to humans. In humans, measuring the antibody response is the
        golden standard to evaluate immune function. If Agaricus bisporus powder indeed has
        beneficial effects on the immune system, people with overweight or obesity and higher age
        might benefit from consuming Agaricus bisporus powder prior to receiving the influenza
        vaccination.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Vaccine specific antibody titer
  time frame: Maximal change form T=0 (change T=0 to T=3 weeks or T=4 weeks)
  description: The response to the Influenza vaccine will be measured by quantifying the specific antibody titer
  measure: Immune parameters (1)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
  measure: Immune parameters (2)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: hsCRP
  measure: Leukocyte count
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Number of leukocytes measured in EDTA plasma
  measure: Leukocyte differential count
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Number of subgroups of leukocytes measured in EDTA plasma
  measure: Fasted metabolism (1)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Serum non-cholesterol sterols and stanols
  measure: Fasted metabolism (2)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Serum lipid and lipoprotein profile
  measure: Fasted metabolism (3)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Plasma glucose
  measure: Fasted metabolism (4)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Ergothioneine
  measure: Fasted metabolism (5)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Glutathione
  measure: Fasted metabolism (6)
  time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
  description: Malondialdehyde
  measure: Anthropometry (1)
  time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
  description: Body weight
  measure: Anthropometry (2)
  time frame: Day -1 (start study)
  description: Height
  measure: Anthropometry (3)
  time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
  description: Waist circumference
  measure: Anthropometry (4)
  time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
  description: Hip circumference
  measure: Anthropometry (5)
  time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
  description: Waist-to-hip ratio
  measure: Diet
  time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
  description: Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume mushrooms outside the intervention
  measure: Quality of life questionnaire
  time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
  description: Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life
  measure: Diary outcomes (1)
  time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
  description: Adverse events as assessed by the diary
  measure: Diary outcomes (2)
  time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
  description: Medication intake as assessed by the diary
  arm group label: Agaricus bisporus group
  arm group type: Experimental
  description: Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder
  intervention type: Biological
  intervention name: Influenza vaccine
  description: Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine
  arm group label: Agaricus bisporus group
  arm group label: Placebo group
  intervention type: Dietary Supplement
  intervention name: Agaricus bisporus capsules
  description: Participants have to consume 10 capsules per day containing 500 mg Agaricus bisporus powder each, corresponding to a total Agariicus bisporus powder intake of 5 g daily
  arm group label: Agaricus bisporus group
  intervention type: Dietary Supplement
  intervention name: Control capsules
  description: Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily
  arm group label: Placebo group
  criteria: 
  gender: All
  minimum age: 59 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Influenza, Human