<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/NCT03825276</url>
  </required_header>
  <id_info>
    <org_study_id>MANGO 2018-147</org_study_id>
    <nct_id>NCT03825276</nct_id>
  </id_info>
  <brief_title>Effect of Mango on Gut Microbiota and Metabolic Health</brief_title>
  <official_title>Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mango is rich in bioactive compounds such as dietary polyphenols and carotenoids, which may&#xD;
      explain its beneficial effect on health. Polyphenols accumulate in the gut where they can&#xD;
      positively modulate the microbiota. As gut microbiota may have a strong influence on&#xD;
      cardiometabolic health, we hypothesize that mango consumption improves metabolic profile in&#xD;
      overweight or obese individuals through beneficial changes in gut microbiota. The study of&#xD;
      metagenomics, transcriptomics and metabolomics will be used to validate this hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hip circumference of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
    <description>Waist and hip circumference will be combined to report waist to hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weight and height will be combined to report BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
    <description>Gene-level expression from &gt;20,000 annotated genes will be examined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
    <description>Metabolites include acylcarnitines, glycerophospholipids, sphingolipids, sugars, amino acids, biogenic amines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
    <description>Stool samples will be collected and whole metagenome shotgun sequencing analysis will be conducted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Gut Microbiota</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Mango consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Mango consumption</intervention_name>
    <description>Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.</description>
    <arm_group_label>Mango consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and premenopausal women&#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;
          -  Caucasian origin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nicotine use&#xD;
&#xD;
          -  Metabolic disorders or use of medication that may affect parameters measured in the&#xD;
             study&#xD;
&#xD;
          -  Use of dietary supplements or natural health product that may affect parameters&#xD;
             measured in the study&#xD;
&#xD;
          -  Use of antibiotics in the last 3 months&#xD;
&#xD;
          -  Surgery in the last 3 months or planned during the study timeline&#xD;
&#xD;
          -  Alcohol consumption &gt;2 drinks/day&#xD;
&#xD;
          -  Weight change &gt;5% in the last 3 months&#xD;
&#xD;
          -  Mango aversion, allergy or intolerance&#xD;
&#xD;
          -  Dietary restrictions (vegetarian, gluten avoidance...)&#xD;
&#xD;
          -  Berries consumption &gt;1 serving/day&#xD;
&#xD;
          -  Pregnancy, breastfeeding or pregnancy planned within 3-6 months&#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>Charles.Couillard@fsaa.ulaval.ca Couillard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laval University</name>
      <address>
        <city>Québec</city>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 5, 2021</last_update_submitted>
  <last_update_submitted_qc>July 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Charles Couillard</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mango</keyword>
  <keyword>Polyphenols</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Transcriptomic</keyword>
  <keyword>Metabolomic</keyword>
  <keyword>Metagenomic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic 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/NCT03825276
org study id: MANGO 2018-147
nct id: NCT03825276
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Mango is rich in bioactive compounds such as dietary polyphenols and carotenoids, which may
      explain its beneficial effect on health. Polyphenols accumulate in the gut where they can
      positively modulate the microbiota. As gut microbiota may have a strong influence on
      cardiometabolic health, we hypothesize that mango consumption improves metabolic profile in
      overweight or obese individuals through beneficial changes in gut microbiota. The study of
      metagenomics, transcriptomics and metabolomics will be used to validate this hypothesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in waist circumference of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in hip circumference of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
description: Waist and hip circumference will be combined to report waist to hip ratio
measure: Height of overweight/obese men and women taking frozen mangos daily
time frame: Baseline
measure: Changes in weight of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
description: Weight and height will be combined to report BMI
measure: Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
description: Gene-level expression from >20,000 annotated genes will be examined
measure: Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
description: Metabolites include acylcarnitines, glycerophospholipids, sphingolipids, sugars, amino acids, biogenic amines
measure: Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
description: Stool samples will be collected and whole metagenome shotgun sequencing analysis will be conducted
measure: Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
measure: Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily
time frame: 8 weeks
arm group label: Mango consumption
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Mango consumption
description: Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.
arm group label: Mango consumption
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles.Couillard@fsaa.ulaval.ca Couillard, PhD
role: Principal Investigator
affiliation: Laval University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Charles Couillard
investigator title: Professor
mesh term: Metabolic Syndrome