<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/NCT03266055</url>
  </required_header>
  <id_info>
    <org_study_id>BLEUET 2017-135</org_study_id>
    <nct_id>NCT03266055</nct_id>
  </id_info>
  <brief_title>Effects of Blueberry on Gut Microbiota and Metabolic Syndrome</brief_title>
  <official_title>Prebiotic Effects of Blueberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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 is growing evidence that nutritional intervention with dietary polyphenols can&#xD;
      positively modulate the gut microbiota to improve cardiometabolic health. Whether the&#xD;
      beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to&#xD;
      their potential impact on the gut microbiota and intestinal integrity remains speculative at&#xD;
      this time. Moreover, the mechanisms of action underlying health benefits associated to&#xD;
      blueberry consumption are still unknown. The investigators are thus proposing to combine the&#xD;
      study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity&#xD;
      of highbush blueberries can play a role in the prevention of obesity-linked metabolic&#xD;
      syndrome in a clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">January 14, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma insulin/glucose of overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma lipids/lipoproteins of overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in gene expression in overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolites concentration in overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the gut microbiota composition in overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure of overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intestinal integrity of overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inflammation biomarkers of overweight/obese men and women taking either blueberry powder or placebo blueberry powder</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Gut Microbiota</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Blueberry powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Blueberry placebo powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>50 g of blueberry powder, taken daily for 8 weeks</intervention_name>
    <description>Subjects will consume blueberry powder during 8 weeks to test the possible effects of blueberries on gut microbiota composition and on metabolic syndrome parameters.</description>
    <arm_group_label>Blueberry powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>50g of placebo blueberry powder, taken daily for 8 weeks</intervention_name>
    <description>Subjects will consume blueberry placebo powder to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatment (blueberry powder).</description>
    <arm_group_label>Blueberry placebo powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and premenopause women in good health&#xD;
&#xD;
          -  Caucasians&#xD;
&#xD;
          -  At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥&#xD;
             80 cm for women and ≥ 94 cm for men&#xD;
&#xD;
          -  At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic disorders (hypertension, diabetes, hypercholesterolemia)&#xD;
&#xD;
          -  Regular use of medication affecting study parameters&#xD;
&#xD;
          -  Use of natural health product in the last 3 months&#xD;
&#xD;
          -  Use of antibiotics in the last 3 months&#xD;
&#xD;
          -  Nicotine users&#xD;
&#xD;
          -  Allergy or intolerance for blueberries&#xD;
&#xD;
          -  Blueberry taste aversion&#xD;
&#xD;
          -  More than 2 alcohol drinks par day&#xD;
&#xD;
          -  Particular dietary habits (vegetarism, gluten-free diet, cetogenic diet...)&#xD;
&#xD;
          -  Weight change of more than 5% in the last 3 months&#xD;
&#xD;
          -  Surgery in the last 3 months or planed during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Claude Vohl</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laval University</name>
      <address>
        <city>Québec</city>
        <zip>G1V0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Marie-Claude Vohl</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Blueberry</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03266055
org study id: BLEUET 2017-135
nct id: NCT03266055
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is growing evidence that nutritional intervention with dietary polyphenols can
      positively modulate the gut microbiota to improve cardiometabolic health. Whether the
      beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to
      their potential impact on the gut microbiota and intestinal integrity remains speculative at
      this time. Moreover, the mechanisms of action underlying health benefits associated to
      blueberry consumption are still unknown. The investigators are thus proposing to combine the
      study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity
      of highbush blueberries can play a role in the prevention of obesity-linked metabolic
      syndrome in a clinical setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Changes in plasma insulin/glucose of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 12 months
measure: Changes in plasma lipids/lipoproteins of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 12 months
measure: Changes in gene expression in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 3-6 months
measure: Changes in metabolites concentration in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 3-6 months
measure: Changes in the gut microbiota composition in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 3-6 months
measure: Changes in blood pressure of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 12 months
measure: Changes in intestinal integrity of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 12 months
measure: Changes in inflammation biomarkers of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
time frame: 12 months
arm group label: Blueberry powder
arm group type: Experimental
arm group label: Blueberry placebo powder
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: 50 g of blueberry powder, taken daily for 8 weeks
description: Subjects will consume blueberry powder during 8 weeks to test the possible effects of blueberries on gut microbiota composition and on metabolic syndrome parameters.
arm group label: Blueberry powder
intervention type: Dietary Supplement
intervention name: 50g of placebo blueberry powder, taken daily for 8 weeks
description: Subjects will consume blueberry placebo powder to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatment (blueberry powder).
arm group label: Blueberry placebo powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie-Claude Vohl
role: Principal Investigator
affiliation: Laval University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Marie-Claude Vohl
investigator title: Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome