<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/NCT03830970</url>
  </required_header>
  <id_info>
    <org_study_id>REB-18-10-045</org_study_id>
    <nct_id>NCT03830970</nct_id>
  </id_info>
  <brief_title>Effect of Canned Beans of Multiple Varieties in Daily Amounts of 1 Cup and 1/2 Cup on Serum LDL Cholesterol and Other Cardiovascular Disease Risk Biomarkers in Adults With Elevated LDL Cholesterol</brief_title>
  <official_title>Effect of Canned Beans of Multiple Varieties in Daily Amounts of 1 Cup and 1/2 Cup on Serum LDL Cholesterol and Other Cardiovascular Disease Risk Biomarkers in Adults With Elevated LDL Cholesterol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Agricultural Partnership Pulse Science Cluster Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Bonduelle Company (providing the canned beans)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Guelph</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 Bean Study will examine the effects of consuming two daily amounts of canned beans of&#xD;
      multiple varieties on fasting serum cholesterol profile in adults with elevated LDL&#xD;
      cholesterol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will&#xD;
      examine the effects of consuming two daily amounts of canned beans of multiple varieties on&#xD;
      fasting serum cholesterol profile in adults with elevated LDL cholesterol. Participants will&#xD;
      consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice&#xD;
      for 4 weeks each, separated by minimum 4-week washout periods. At the start and end of each&#xD;
      4-week treatment period, fasting blood samples will be collected and analyzed for lipids,&#xD;
      glucose insulin and short chain fatty acids (SCFAs). Fecal samples will also be collected and&#xD;
      analyzed for SCFA, bile acids and gut microbiota. Body weight and BMI will be also be&#xD;
      measured at the start and end as well as mid-way of each treatment period. Finally 3-day food&#xD;
      records will be completed mid-way during each treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">January 5, 2021</completion_date>
  <primary_completion_date type="Actual">January 5, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting serum LDL cholesterol</measure>
    <time_frame>4 weeks (28 days)</time_frame>
    <description>Fasting serum LDL cholesterol will be compared among treatments at study day 29 using ANCOVA and including study day 1 as a covariate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting serum total cholesterol, HDL cholesterol and triglycerides</measure>
    <time_frame>4 weeks (28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum glucose and insulin and HOMA-IR</measure>
    <time_frame>4 weeks (28 days)</time_frame>
    <description>Fasting glucose and insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum and fecal short chain fatty acids</measure>
    <time_frame>4 weeks (28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal bile acids</measure>
    <time_frame>4 weeks (28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut Microbiota</measure>
    <time_frame>4 weeks (28 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Hypercholesterolemia</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>1 cup of canned beans of multiple varieties</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1/2 cup of canned beans of multiple varieties</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 cup of White rice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Consumption of 1 cup of white rice each day for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Canned beans of multiple varieties</intervention_name>
    <description>Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney</description>
    <arm_group_label>1 cup of canned beans of multiple varieties</arm_group_label>
    <arm_group_label>1/2 cup of canned beans of multiple varieties</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>White Rice</intervention_name>
    <description>Minute Rice Long Grain White Rice</description>
    <arm_group_label>1 cup of White rice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adults (≥18 years)&#xD;
&#xD;
          -  BMI 18.5-35 kg/m2&#xD;
&#xD;
          -  LDL cholesterol 3.0-5.0 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Triglycerides ≥3.0 mmol/L&#xD;
&#xD;
          -  Diabetes (fasting blood glucose ≥7.0 mmol/L)&#xD;
&#xD;
          -  Blood pressure &gt;140/90 mmHg&#xD;
&#xD;
          -  Major medical conditions&#xD;
&#xD;
          -  Medical or surgical events requiring hospitalization within the last 3 months&#xD;
&#xD;
          -  Medication use that would interfere with the study outcomes (e.g. cholesterol-lowering&#xD;
             medications, diabetes-related medications, steroids). All other medications are okay&#xD;
             if at a stable (3-month) dose&#xD;
&#xD;
          -  Antibiotic use within the last 3 months&#xD;
&#xD;
          -  Tobacco product use (&gt;5 times per week)&#xD;
&#xD;
          -  Cannabis use during the study&#xD;
&#xD;
          -  Probiotic supplement use (could do a 1-month washout before study)&#xD;
&#xD;
          -  Dietary fibre supplement use (could do a 1-month washout before study)&#xD;
&#xD;
          -  NHPs used for cholesterol lowering or glycemic control. All other NHPs are okay if at&#xD;
             a stable (3-month) dose.&#xD;
&#xD;
          -  Pulse consumption &gt;4 servings per week&#xD;
&#xD;
          -  Food allergy or non-food life-threatening allergy&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Alcohol consumption (&gt;14 drinks/week or &gt;4 drinks/sitting)&#xD;
&#xD;
          -  Recent or intended significant weight loss or gain (&gt;4 kg in previous 3 months)&#xD;
&#xD;
          -  National-level or professional athlete&#xD;
&#xD;
          -  Overnight shift worker&#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>
  <location>
    <facility>
      <name>Human Nutraceutical Research Unit</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glycemic Index Laboratories, Inc</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guelph</investigator_affiliation>
    <investigator_full_name>Alison Duncan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mixed Beans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03830970
org study id: REB-18-10-045
nct id: NCT03830970
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Bean Study will examine the effects of consuming two daily amounts of canned beans of
      multiple varieties on fasting serum cholesterol profile in adults with elevated LDL
      cholesterol.
The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will
      examine the effects of consuming two daily amounts of canned beans of multiple varieties on
      fasting serum cholesterol profile in adults with elevated LDL cholesterol. Participants will
      consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice
      for 4 weeks each, separated by minimum 4-week washout periods. At the start and end of each
      4-week treatment period, fasting blood samples will be collected and analyzed for lipids,
      glucose insulin and short chain fatty acids (SCFAs). Fecal samples will also be collected and
      analyzed for SCFA, bile acids and gut microbiota. Body weight and BMI will be also be
      measured at the start and end as well as mid-way of each treatment period. Finally 3-day food
      records will be completed mid-way during each treatment period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fasting serum LDL cholesterol
time frame: 4 weeks (28 days)
description: Fasting serum LDL cholesterol will be compared among treatments at study day 29 using ANCOVA and including study day 1 as a covariate
measure: Fasting serum total cholesterol, HDL cholesterol and triglycerides
time frame: 4 weeks (28 days)
measure: Fasting serum glucose and insulin and HOMA-IR
time frame: 4 weeks (28 days)
description: Fasting glucose and insulin
measure: Fasting serum and fecal short chain fatty acids
time frame: 4 weeks (28 days)
measure: Fecal bile acids
time frame: 4 weeks (28 days)
measure: Gut Microbiota
time frame: 4 weeks (28 days)
arm group label: 1 cup of canned beans of multiple varieties
arm group type: Experimental
description: Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks
arm group label: 1/2 cup of canned beans of multiple varieties
arm group type: Experimental
description: Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks
arm group label: 1 cup of White rice
arm group type: Other
description: Consumption of 1 cup of white rice each day for 4 weeks
intervention type: Dietary Supplement
intervention name: Canned beans of multiple varieties
description: Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
arm group label: 1 cup of canned beans of multiple varieties
arm group label: 1/2 cup of canned beans of multiple varieties
intervention type: Dietary Supplement
intervention name: White Rice
description: Minute Rice Long Grain White Rice
arm group label: 1 cup of White rice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Guelph
investigator full name: Alison Duncan
investigator title: Professor
mesh term: Cardiovascular Diseases
mesh term: Hypercholesterolemia
sharing ipd: No