<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/NCT01661543</url>
  </required_header>
  <id_info>
    <org_study_id>QFH-11-044</org_study_id>
    <nct_id>NCT01661543</nct_id>
  </id_info>
  <brief_title>U of A/ U of M Beans and Peas Health Claim Project</brief_title>
  <official_title>Substantiating a Health Claim for Pulses (Beans and Peas) and Cholesterol Lowering Abilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pulse Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare how regularly eating (dried) beans or peas or rice&#xD;
      (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total&#xD;
      cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that&#xD;
      regularly eating beans or peas will significantly improve blood lipid profiles in these&#xD;
      people.&#xD;
&#xD;
      Participants in this study will consume 1 study food item 5 out of 7 days a week containing&#xD;
      beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers&#xD;
      by enhancing development of food products for human consumption and supporting marketing&#xD;
      strategies to increase awareness that a diet rich in pulses can improve human health.&#xD;
      Measuring changes in blood and urinary polyphenol levels will help to verify whether these&#xD;
      compounds play a role in the beneficial actions of beans and peas and subsequently assist&#xD;
      with the identification of the beneficial bean/pea components. This in turn, will enable crop&#xD;
      breeders to select for plants that are rich in these compounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES: The aim of this study is to conduct a multi-centre randomized, controlled trial&#xD;
      to specifically compare the biological effectiveness of bean versus peas vs rice (control) on&#xD;
      LDL-cholesterol in mildly hypercholesterolemic men and women. In addition, the effects of&#xD;
      beans and peas on other key factors associated with cardiovascular disease, including&#xD;
      triglycerides, High Density Lipoprotein-cholesterol, body weight/fatness, glucose, insulin,&#xD;
      glycated hemoglobin and biomarkers of vascular function. Inflammation and metabolism will be&#xD;
      investigated, as well as the participants' assessment of study food acceptability, satiety&#xD;
      and gastrointestinal responses.&#xD;
&#xD;
      BACKGROUND: Pulses (beans, peas, lentils and chickpeas) are healthy foods that contain twice&#xD;
      the amount of protein as cereals, are very high in fibre, key vitamins and minerals like&#xD;
      folate and iron and are low in fat. Canada is the world's largest producer and exporter of&#xD;
      lentils and peas, and Alberta produced 34% of the pea crop and 12% of beans in 2010. Current&#xD;
      consumption of pulses in Canada is low, due to a lack of pulse-based convenient food&#xD;
      products. An approved health claim can drive interest in development of food products with&#xD;
      particular ingredients as seen with oat beta-glucan. Experts agree that existing evidence for&#xD;
      the cholesterol-lowering effects of pulses is particularly strong for beans, but more studies&#xD;
      are needed to show the effects of peas, lentils and chickpeas are comparable to beans.&#xD;
      Results from this study will be used to substantiate a health claim for beans and other pulse&#xD;
      crops in the future, similar to the health claims that exist for beta-glucan and plant&#xD;
      sterols.&#xD;
&#xD;
      METHODS AND PROCEDURES: This multi-center study will compare the effects of beans (pinto,&#xD;
      black, Great Northern, small red) versus peas (yellow, green) to control (rice-based) foods&#xD;
      on total and Low Density Lipoprotein-Cholesterol in mildly hypercholesterolemic (&gt;3 mmol/L&#xD;
      and &lt; 5mmol/L; not on medications) adults. There will be 3 study arms: i) beans, ii) peas,&#xD;
      and iii) rice (control). The study groups will be asked to consume food items containing 120&#xD;
      grams of cooked beans or cooked peas daily for 6 weeks. The control group will be asked to&#xD;
      consume one 1/2 cup serving per day of rice-based foods in matrices similar to those&#xD;
      containing beans or peas for 6 weeks. The study or control foods will be incorporated into&#xD;
      the participants normal dietary pattern. All food items will be provided to participants free&#xD;
      of charge. Food items, generally in the form of soups or stews, will be developed by a&#xD;
      collaborator in Food Science at the University of Manitoba in the initial phase of this&#xD;
      project .&#xD;
&#xD;
      The investigators plan to recruit approximately 180 participants (n= 75 participants at the&#xD;
      University of Manitoba and n= 105 at University of Alberta). Interested individuals&#xD;
      (potential participants) will be first asked to attend a screening visit. The screening visit&#xD;
      procedures will be discussed prior to the screening visit, including the need to fast (i.e.,&#xD;
      no food or beverage intake except water for 12 hours) for blood sampling to determine if&#xD;
      Low-density-lipoprotein-cholesterol and triglyceride levels are within acceptable range. Once&#xD;
      at this visit, individuals will be provided with a description of the study by the&#xD;
      investigating team's study coordinator. The eligibility criteria will be reviewed with&#xD;
      candidates by the investigating team's study coordinator to assess their suitability for the&#xD;
      study. Individuals meeting all inclusion/exclusion criteria will be contacted by the study&#xD;
      coordinator with this information. All individuals who are screened will be contacted by the&#xD;
      study coordinator once eligibility has been confirmed. An appointment for a baseline&#xD;
      assessment meeting will be scheduled for those who are eligible and who confirm interest in&#xD;
      the study; those who are not eligible or who are eligible and no longer wish to participate&#xD;
      will be thanked for their time.&#xD;
&#xD;
      At the baseline assessment visit individuals will be reminded of the study description and&#xD;
      will be asked to provide written informed consent at this time.&#xD;
&#xD;
      Once enrolled, participants will undergo a complete medical history including age, sex,&#xD;
      alcohol use, exercise habits, current medical problems, medication and family history of&#xD;
      previous events such as stroke and diabetes. A fasting blood sample will be obtained to&#xD;
      assess plasma lipid profile.&#xD;
&#xD;
      Participants will be asked to attend 4 in-person clinic visits over the duration of the study&#xD;
      for screening, baseline assessment, and at 3 and 6 weeks (at the end of the study).&#xD;
&#xD;
      Once identified and after giving informed consent, participants will be randomized to one of&#xD;
      the 3 study arms. The randomization will be either computer generated, or done manually by a&#xD;
      study coordinator for both sites. Each participant will be given a randomized number, and&#xD;
      will be used for all study documentation.&#xD;
&#xD;
      Participants will fill out questionnaire relating to demographics, lifestyle, food intake,&#xD;
      gastrointestinal responses etc.&#xD;
&#xD;
      The baseline visit will include a height and weight measurement, waist circumference and body&#xD;
      composition using the Bod Pod machine (air displacement) Blood pressure will be recorded.&#xD;
      Participants will be assessed for changes in their medication profile and discuss current&#xD;
      medical conditions. The three day food record (completed at home) will be collected. Urine&#xD;
      sample and fasting blood sample will be drawn for lipid assessment profile, insulin, glucose,&#xD;
      glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation and&#xD;
      metabolism. Blood required will not exceed 60mL.&#xD;
&#xD;
      Randomization will be done at the baseline visit. Prior to leaving, participants will be&#xD;
      provided with the first 3-week supply of assigned foods and instruction about how to prepare&#xD;
      and consume them, and will be reminded to fast before their next visit. This visit will take&#xD;
      approximately 2.5 hours.&#xD;
&#xD;
      Week 3 visit will include height and weight measurements, waist circumference and body&#xD;
      composition using Bod Pod (via air displacement). Blood pressure will be recorded.&#xD;
      Participants will be assessed for changes in their medication profile and current medical&#xD;
      conditions. The 3 day food record (completed at home) will be collected. Urine sample will be&#xD;
      collected. Fasting blood sample will be drawn for assessment of lipid profile, insulin,&#xD;
      glucose, glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation&#xD;
      and metabolism. The total blood required will not exceed 60mL.&#xD;
&#xD;
      Participants will complete a questionnaire to assess compliance, acceptability of the study&#xD;
      foods, satiety, GI responses and any adverse events. Questions will be addressed. Before&#xD;
      leaving, participants will be provided with the second 3-week supply of assigned foods, and&#xD;
      instructions about how to prepare and consume them. Participants will be reminded to fast&#xD;
      prior to next visit. Visit will take approximately 2 hours.&#xD;
&#xD;
      Week 6 visit: Measurements taken for height and weight, waist circumference, body composition&#xD;
      using Bod Pod (air displacement) and blood pressure will be repeated. Participants will be&#xD;
      assessed for changes in their medication profile and current medical conditions. Urine sample&#xD;
      will be collected for polyphenols. A fasting blood sample will be drawn for assessment of&#xD;
      lipid profile, insulin, glucose, glycated hemoglobin, polyphenols, and biomarkers of vascular&#xD;
      function (University of Manitoba only), inflammation and metabolism. Total blood will not&#xD;
      exceed 60 mL. Participants will complete a questionnaire to assess compliance, acceptability&#xD;
      of the foods, satiety, Gastrointestinal responses and any adverse events. Total time&#xD;
      required, approximately 2.5 hours. Completion of this visit marks the end of the study.&#xD;
      Participants will be paid, and thanked for their time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lowering of Cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Cholesterol will be tested at Baseline, 3 and 6 week interval</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Bean consumption to lower cholesterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will consume 90 grams of beans per day for 5 out of 7 days for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (rice) consumed to show results</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will consume 90 grams of rice per day for 5 out of 7 days for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peas consumed to lower cholesterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will consume 90g of peas per day for 5 days out of each week for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beans</intervention_name>
    <description>90g of beans per day for 5 out of 7 days per week will be given to participants for 6 weeks to determine the cholesterol lowering effects of various pulses.</description>
    <arm_group_label>Bean consumption to lower cholesterol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control (rice)</intervention_name>
    <description>90g of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group.</description>
    <arm_group_label>Control (rice) consumed to show results</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Peas</intervention_name>
    <description>90 grams of peas will be consumed 5 out of 7 days per week</description>
    <arm_group_label>Peas consumed to lower cholesterol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, or non-pregnant, non-lactating females, aged 20 to 75 years; This age range&#xD;
             allows for a large variety of participants.&#xD;
&#xD;
          -  LDL-cholesterol &gt;3.00 mmol/L and &lt;5.00 mmol/L; Cholesterol is high enough that a&#xD;
             lowering can be seen, but low enough that the participant is not taking medications or&#xD;
             alternative measures to lower cholesterol.&#xD;
&#xD;
          -  Fasting triglycerides &lt;4.00 mmol/L; Low enough that it is not dangerous to&#xD;
             participant, but high enough to see a lowering effect.&#xD;
&#xD;
          -  Stable body weight (±5%) for the past 3 months and BMI of 20-40; Participants with&#xD;
             high BMI are more likely to have high lipid levels, it is important to have a stable&#xD;
             body weight so energy requirements are not drastically changing during the study&#xD;
             period.&#xD;
&#xD;
          -  Must be on a stable regime for the past 3 months if taking medications or if taking&#xD;
             vitamin and mineral/dietary/herbal supplements; Stable regime reduces risk of any&#xD;
             changes during study.&#xD;
&#xD;
          -  Able to read, write and communicate orally in English; All questionnaires and&#xD;
             communication will be completed in English.&#xD;
&#xD;
        Willing to comply with the protocol requirements, including a stable level of physical&#xD;
        activity during the study and no other pulse-containing foods consumed during the study;&#xD;
        this will ensure the most valid results.&#xD;
&#xD;
        Willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular high pulse consumption (&gt;2 servings per week); Any additional pulse&#xD;
             consumption will affect the outcome of the study.&#xD;
&#xD;
          -  Use of medications to lower blood lipids or to lower blood glucose; the aim of the&#xD;
             study is to prove the cholesterol lowering capabilities of beans and peas, any other&#xD;
             methods of blood lipid lowering will skew data.&#xD;
&#xD;
          -  Use of non-prescription products designed to lower blood lipids (e.g. margarine or&#xD;
             yogurt with added plant sterols) within the past 3 months; see above&#xD;
&#xD;
          -  Medical history of liver disease, renal insufficiency, inflammatory bowel disease or&#xD;
             other gastrointestinal disorders influencing gastrointestinal motility or nutrient&#xD;
             absorption; this will decrease effectiveness of bean/ consumption.&#xD;
&#xD;
          -  Any active medical or surgical condition(s) within the past 3 months precluding study&#xD;
             participation; participants must be in a stable condition with no recovery or pending&#xD;
             surgery.&#xD;
&#xD;
          -  Conditions or medications which are likely to increase the risk to the participants or&#xD;
             study personnel, or to reduce the ability of the participant to comply with the&#xD;
             protocol, or affect the results;&#xD;
&#xD;
          -  History of gastrointestinal reactions or allergies to beans, peas or rice-based foods,&#xD;
             or to one or more ingredients in the study foods which significantly limits the number&#xD;
             of study foods that can be consumed.&#xD;
&#xD;
          -  Currently participating in or having participated in a food intervention study within&#xD;
             the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rhonda C Bell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda McCargar, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cathy Chan, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Spencer Proctor, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jocelyn Ozga, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Wishart, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carla Taylor, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Zahradka, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Aliani, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>December 22, 2015</last_update_submitted>
  <last_update_submitted_qc>December 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</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/NCT01661543
org study id: QFH-11-044
nct id: NCT01661543
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to compare how regularly eating (dried) beans or peas or rice
      (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total
      cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that
      regularly eating beans or peas will significantly improve blood lipid profiles in these
      people.

      Participants in this study will consume 1 study food item 5 out of 7 days a week containing
      beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers
      by enhancing development of food products for human consumption and supporting marketing
      strategies to increase awareness that a diet rich in pulses can improve human health.
      Measuring changes in blood and urinary polyphenol levels will help to verify whether these
      compounds play a role in the beneficial actions of beans and peas and subsequently assist
      with the identification of the beneficial bean/pea components. This in turn, will enable crop
      breeders to select for plants that are rich in these compounds.
OBJECTIVES: The aim of this study is to conduct a multi-centre randomized, controlled trial
      to specifically compare the biological effectiveness of bean versus peas vs rice (control) on
      LDL-cholesterol in mildly hypercholesterolemic men and women. In addition, the effects of
      beans and peas on other key factors associated with cardiovascular disease, including
      triglycerides, High Density Lipoprotein-cholesterol, body weight/fatness, glucose, insulin,
      glycated hemoglobin and biomarkers of vascular function. Inflammation and metabolism will be
      investigated, as well as the participants' assessment of study food acceptability, satiety
      and gastrointestinal responses.

      BACKGROUND: Pulses (beans, peas, lentils and chickpeas) are healthy foods that contain twice
      the amount of protein as cereals, are very high in fibre, key vitamins and minerals like
      folate and iron and are low in fat. Canada is the world's largest producer and exporter of
      lentils and peas, and Alberta produced 34% of the pea crop and 12% of beans in 2010. Current
      consumption of pulses in Canada is low, due to a lack of pulse-based convenient food
      products. An approved health claim can drive interest in development of food products with
      particular ingredients as seen with oat beta-glucan. Experts agree that existing evidence for
      the cholesterol-lowering effects of pulses is particularly strong for beans, but more studies
      are needed to show the effects of peas, lentils and chickpeas are comparable to beans.
      Results from this study will be used to substantiate a health claim for beans and other pulse
      crops in the future, similar to the health claims that exist for beta-glucan and plant
      sterols.

      METHODS AND PROCEDURES: This multi-center study will compare the effects of beans (pinto,
      black, Great Northern, small red) versus peas (yellow, green) to control (rice-based) foods
      on total and Low Density Lipoprotein-Cholesterol in mildly hypercholesterolemic (>3 mmol/L
      and < 5mmol/L; not on medications) adults. There will be 3 study arms: i) beans, ii) peas,
      and iii) rice (control). The study groups will be asked to consume food items containing 120
      grams of cooked beans or cooked peas daily for 6 weeks. The control group will be asked to
      consume one 1/2 cup serving per day of rice-based foods in matrices similar to those
      containing beans or peas for 6 weeks. The study or control foods will be incorporated into
      the participants normal dietary pattern. All food items will be provided to participants free
      of charge. Food items, generally in the form of soups or stews, will be developed by a
      collaborator in Food Science at the University of Manitoba in the initial phase of this
      project .

      The investigators plan to recruit approximately 180 participants (n= 75 participants at the
      University of Manitoba and n= 105 at University of Alberta). Interested individuals
      (potential participants) will be first asked to attend a screening visit. The screening visit
      procedures will be discussed prior to the screening visit, including the need to fast (i.e.,
      no food or beverage intake except water for 12 hours) for blood sampling to determine if
      Low-density-lipoprotein-cholesterol and triglyceride levels are within acceptable range. Once
      at this visit, individuals will be provided with a description of the study by the
      investigating team's study coordinator. The eligibility criteria will be reviewed with
      candidates by the investigating team's study coordinator to assess their suitability for the
      study. Individuals meeting all inclusion/exclusion criteria will be contacted by the study
      coordinator with this information. All individuals who are screened will be contacted by the
      study coordinator once eligibility has been confirmed. An appointment for a baseline
      assessment meeting will be scheduled for those who are eligible and who confirm interest in
      the study; those who are not eligible or who are eligible and no longer wish to participate
      will be thanked for their time.

      At the baseline assessment visit individuals will be reminded of the study description and
      will be asked to provide written informed consent at this time.

      Once enrolled, participants will undergo a complete medical history including age, sex,
      alcohol use, exercise habits, current medical problems, medication and family history of
      previous events such as stroke and diabetes. A fasting blood sample will be obtained to
      assess plasma lipid profile.

      Participants will be asked to attend 4 in-person clinic visits over the duration of the study
      for screening, baseline assessment, and at 3 and 6 weeks (at the end of the study).

      Once identified and after giving informed consent, participants will be randomized to one of
      the 3 study arms. The randomization will be either computer generated, or done manually by a
      study coordinator for both sites. Each participant will be given a randomized number, and
      will be used for all study documentation.

      Participants will fill out questionnaire relating to demographics, lifestyle, food intake,
      gastrointestinal responses etc.

      The baseline visit will include a height and weight measurement, waist circumference and body
      composition using the Bod Pod machine (air displacement) Blood pressure will be recorded.
      Participants will be assessed for changes in their medication profile and discuss current
      medical conditions. The three day food record (completed at home) will be collected. Urine
      sample and fasting blood sample will be drawn for lipid assessment profile, insulin, glucose,
      glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation and
      metabolism. Blood required will not exceed 60mL.

      Randomization will be done at the baseline visit. Prior to leaving, participants will be
      provided with the first 3-week supply of assigned foods and instruction about how to prepare
      and consume them, and will be reminded to fast before their next visit. This visit will take
      approximately 2.5 hours.

      Week 3 visit will include height and weight measurements, waist circumference and body
      composition using Bod Pod (via air displacement). Blood pressure will be recorded.
      Participants will be assessed for changes in their medication profile and current medical
      conditions. The 3 day food record (completed at home) will be collected. Urine sample will be
      collected. Fasting blood sample will be drawn for assessment of lipid profile, insulin,
      glucose, glycated hemoglobin, polyphenols and biomarkers of vascular function, inflammation
      and metabolism. The total blood required will not exceed 60mL.

      Participants will complete a questionnaire to assess compliance, acceptability of the study
      foods, satiety, GI responses and any adverse events. Questions will be addressed. Before
      leaving, participants will be provided with the second 3-week supply of assigned foods, and
      instructions about how to prepare and consume them. Participants will be reminded to fast
      prior to next visit. Visit will take approximately 2 hours.

      Week 6 visit: Measurements taken for height and weight, waist circumference, body composition
      using Bod Pod (air displacement) and blood pressure will be repeated. Participants will be
      assessed for changes in their medication profile and current medical conditions. Urine sample
      will be collected for polyphenols. A fasting blood sample will be drawn for assessment of
      lipid profile, insulin, glucose, glycated hemoglobin, polyphenols, and biomarkers of vascular
      function (University of Manitoba only), inflammation and metabolism. Total blood will not
      exceed 60 mL. Participants will complete a questionnaire to assess compliance, acceptability
      of the foods, satiety, Gastrointestinal responses and any adverse events. Total time
      required, approximately 2.5 hours. Completion of this visit marks the end of the study.
      Participants will be paid, and thanked for their time.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lowering of Cholesterol
time frame: 6 weeks
description: Cholesterol will be tested at Baseline, 3 and 6 week interval
arm group label: Bean consumption to lower cholesterol
arm group type: Experimental
description: This arm will consume 90 grams of beans per day for 5 out of 7 days for 6 weeks.
arm group label: Control (rice) consumed to show results
arm group type: Placebo Comparator
description: The control group will consume 90 grams of rice per day for 5 out of 7 days for 6 weeks.
arm group label: Peas consumed to lower cholesterol
arm group type: Experimental
description: This arm will consume 90g of peas per day for 5 days out of each week for 6 weeks.
intervention type: Dietary Supplement
intervention name: Beans
description: 90g of beans per day for 5 out of 7 days per week will be given to participants for 6 weeks to determine the cholesterol lowering effects of various pulses.
arm group label: Bean consumption to lower cholesterol
intervention type: Dietary Supplement
intervention name: Control (rice)
description: 90g of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group.
arm group label: Control (rice) consumed to show results
intervention type: Dietary Supplement
intervention name: Peas
description: 90 grams of peas will be consumed 5 out of 7 days per week
arm group label: Peas consumed to lower cholesterol
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rhonda C Bell, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Linda McCargar, PhD
role: Study Chair
affiliation: University of Alberta
last name: Cathy Chan, PhD
role: Study Chair
affiliation: university
last name: Spencer Proctor, PhD
role: Study Chair
affiliation: University of Alberta
last name: Jocelyn Ozga, PhD
role: Study Chair
affiliation: University of Alberta
last name: David Wishart, PhD
role: Study Chair
affiliation: University of Alberta
last name: Carla Taylor, PhD
role: Study Chair
affiliation: University of Manitoba
last name: Peter Zahradka, PhD
role: Study Chair
affiliation: University of Manitoba
last name: Michel Aliani, PhD
role: Study Chair
affiliation: University of Manitoba
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hypercholesterolemia