<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/NCT01719900</url>
  </required_header>
  <id_info>
    <org_study_id>24804</org_study_id>
    <nct_id>NCT01719900</nct_id>
  </id_info>
  <brief_title>Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome</brief_title>
  <official_title>Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Innovates Bio Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Pulse Growers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recent dramatic increase in obesity has been linked to a reduction of dietary fibre&#xD;
      intake. We hypothesized that supplementing the diet of overweight and obesity adults with&#xD;
      pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.&#xD;
      Other metabolic health improvements may include improved glucose control and reduced&#xD;
      inflammatory markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of our study is to assess the effects of pulse fibre supplementation on&#xD;
      weight loss in an overweight and obese adult population.&#xD;
&#xD;
      Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre&#xD;
      on weight loss supported by body composition measures.&#xD;
&#xD;
      Secondary objective - To measure glucose control and appetite regulation in overweight and&#xD;
      obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use&#xD;
      of plasma HbA1c and an oral glucose tolerance test (OGTT).&#xD;
&#xD;
      Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by&#xD;
      determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics&#xD;
      and fecal short-chain fatty acid and bile acid concentrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fat Mass at 12 Weeks</measure>
    <time_frame>Value at 12 weeks minus value at baseline</time_frame>
    <description>Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessed via HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Objective Appetite at 12 Weeks</measure>
    <time_frame>12 weeks minus baseline</time_frame>
    <description>Value at 12 weeks minus baseline energy intake during weighed lunch buffet.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cholesterol Profile at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Serum LDL (low density lipoprotein) cholesterol</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Cytokine at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Serum cytokine IL-6 measured at 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Alpha Diversity of Gut Microbiota at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Metabolomics at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fecal Short-chain Fatty Acid Concentrations</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fecal acetate concentration measured at 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Fecal Bile Acid Concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fecal cholic acid concentration measured at 12 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Pulse Fibre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pulse fibre</intervention_name>
    <description>Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
    <arm_group_label>Pulse Fibre</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Control biscuit with no yellow pea hull fibre.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age 18 - 70 years&#xD;
&#xD;
          -  BMI 25 - 38 kg/m-2&#xD;
&#xD;
          -  Stable body weight for at least 3 months prior to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant use of any weight loss medication, diet or exercise regime&#xD;
&#xD;
          -  Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering&#xD;
             medication, diabetes medications&#xD;
&#xD;
          -  Previous bariatric or other intestinal surgeries&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Weight loss &gt; 3 kg within preceding 3 months to enrollment&#xD;
&#xD;
          -  Use of bulk laxatives or probiotics/prebiotics supplements&#xD;
&#xD;
          -  Antibiotic use in the past month&#xD;
&#xD;
          -  Clinically significant cardiovascular or respiratory or liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raylene Reimer, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Lambert JE, Parnell JA, Han J, Sturzenegger T, Paul HA, Vogel HJ, Reimer RA. Evaluation of yellow pea fibre supplementation on weight loss and the gut microbiota: a randomized controlled trial. BMC Gastroenterol. 2014 Apr 8;14:69. doi: 10.1186/1471-230X-14-69.</citation>
    <PMID>24712378</PMID>
  </reference>
  <results_reference>
    <citation>Lambert JE, Parnell JA, Tunnicliffe JM, Han J, Sturzenegger T, Reimer RA. Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial. Clin Nutr. 2017 Feb;36(1):126-133. doi: 10.1016/j.clnu.2015.12.016. Epub 2016 Jan 11.</citation>
    <PMID>26811130</PMID>
  </results_reference>
  <results_reference>
    <citation>Mayengbam S, Lambert JE, Parnell JA, Tunnicliffe JM, Nicolucci AC, Han J, Sturzenegger T, Shearer J, Mickiewicz B, Vogel HJ, Madsen KL, Reimer RA. Impact of dietary fiber supplementation on modulating microbiota-host-metabolic axes in obesity. J Nutr Biochem. 2019 Feb;64:228-236. doi: 10.1016/j.jnutbio.2018.11.003. Epub 2018 Nov 26.</citation>
    <PMID>30572270</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>April 15, 2019</results_first_submitted>
  <results_first_submitted_qc>January 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 21, 2020</results_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Raylene Reimer</investigator_full_name>
    <investigator_title>Professor, Faculty of Kinesiology</investigator_title>
  </responsible_party>
  <keyword>Dietary intervention</keyword>
  <keyword>Dietary fibre</keyword>
  <keyword>Obesity</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Glucose regulation</keyword>
  <keyword>Pulse fibre</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pulse Fibre</title>
          <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pulse Fibre</title>
          <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.5" spread="8.1"/>
                    <measurement group_id="B2" value="44.3" spread="9.5"/>
                    <measurement group_id="B3" value="43.9" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Fat Mass at 12 Weeks</title>
        <description>Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.</description>
        <time_frame>Value at 12 weeks minus value at baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fat Mass at 12 Weeks</title>
          <description>Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" spread="0.26"/>
                    <measurement group_id="O2" value="0.42" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HbA1c at 12 Weeks</title>
        <description>Assessed via HbA1c</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c at 12 Weeks</title>
          <description>Assessed via HbA1c</description>
          <units>% in blood</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.68" spread="0.11"/>
                    <measurement group_id="O2" value="5.89" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Objective Appetite at 12 Weeks</title>
        <description>Value at 12 weeks minus baseline energy intake during weighed lunch buffet.</description>
        <time_frame>12 weeks minus baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Objective Appetite at 12 Weeks</title>
          <description>Value at 12 weeks minus baseline energy intake during weighed lunch buffet.</description>
          <units>% of baseline food intake</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16" spread="6"/>
                    <measurement group_id="O2" value="5" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cholesterol Profile at 12 Weeks</title>
        <description>Serum LDL (low density lipoprotein) cholesterol</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Cholesterol Profile at 12 Weeks</title>
          <description>Serum LDL (low density lipoprotein) cholesterol</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread=".22"/>
                    <measurement group_id="O2" value="2.90" spread=".21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Serum Cytokine at 12 Weeks</title>
        <description>Serum cytokine IL-6 measured at 12 weeks</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Cytokine at 12 Weeks</title>
          <description>Serum cytokine IL-6 measured at 12 weeks</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.20"/>
                    <measurement group_id="O2" value="1.28" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Alpha Diversity of Gut Microbiota at 12 Weeks</title>
        <description>Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Alpha Diversity of Gut Microbiota at 12 Weeks</title>
          <description>Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.</description>
          <units>Score on a scale of 1-4000</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493" spread="132"/>
                    <measurement group_id="O2" value="512" spread="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Serum Metabolomics at 12 Weeks</title>
        <description>Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Metabolomics at 12 Weeks</title>
          <description>Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.</description>
          <units>score on a scale of 1-100%</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fecal Short-chain Fatty Acid Concentrations</title>
        <description>Fecal acetate concentration measured at 12 weeks</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Short-chain Fatty Acid Concentrations</title>
          <description>Fecal acetate concentration measured at 12 weeks</description>
          <units>µmol/g dry weight</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.7" spread="15.5"/>
                    <measurement group_id="O2" value="82.99" spread="12.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fecal Bile Acid Concentration</title>
        <description>Fecal cholic acid concentration measured at 12 weeks</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulse Fibre</title>
            <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
          </group>
        </group_list>
        <measure>
          <title>Fecal Bile Acid Concentration</title>
          <description>Fecal cholic acid concentration measured at 12 weeks</description>
          <units>µmol/g dry weight</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="0.14"/>
                    <measurement group_id="O2" value="1.99" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>53 assessed for serious adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Pulse Fibre</title>
          <description>The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Pulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.&#xD;
Control: Control biscuit with no yellow pea hull fibre.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Raylene Reimer</name_or_title>
      <organization>University of Calgary</organization>
      <phone>14032208218</phone>
      <email>reimer@ucalgary.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01719900
org study id: 24804
nct id: NCT01719900
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The recent dramatic increase in obesity has been linked to a reduction of dietary fibre
      intake. We hypothesized that supplementing the diet of overweight and obesity adults with
      pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.
      Other metabolic health improvements may include improved glucose control and reduced
      inflammatory markers.
The main objective of our study is to assess the effects of pulse fibre supplementation on
      weight loss in an overweight and obese adult population.

      Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre
      on weight loss supported by body composition measures.

      Secondary objective - To measure glucose control and appetite regulation in overweight and
      obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use
      of plasma HbA1c and an oral glucose tolerance test (OGTT).

      Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by
      determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics
      and fecal short-chain fatty acid and bile acid concentrations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Fat Mass at 12 Weeks
time frame: Value at 12 weeks minus value at baseline
description: Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
measure: HbA1c at 12 Weeks
time frame: 12 weeks
description: Assessed via HbA1c
measure: Change in Objective Appetite at 12 Weeks
time frame: 12 weeks minus baseline
description: Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
measure: Cholesterol Profile at 12 Weeks
time frame: 12 weeks
description: Serum LDL (low density lipoprotein) cholesterol
measure: Serum Cytokine at 12 Weeks
time frame: 12 weeks
description: Serum cytokine IL-6 measured at 12 weeks
measure: Alpha Diversity of Gut Microbiota at 12 Weeks
time frame: 12 weeks
description: Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.
measure: Serum Metabolomics at 12 Weeks
time frame: 12 weeks
description: Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.
measure: Fecal Short-chain Fatty Acid Concentrations
time frame: 12 weeks
description: Fecal acetate concentration measured at 12 weeks
measure: Fecal Bile Acid Concentration
time frame: 12 weeks
description: Fecal cholic acid concentration measured at 12 weeks
arm group label: Pulse Fibre
arm group type: Experimental
description: The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
arm group label: Control
arm group type: Placebo Comparator
description: The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
intervention type: Dietary Supplement
intervention name: Pulse fibre
description: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
arm group label: Pulse Fibre
intervention type: Dietary Supplement
intervention name: Control
description: Control biscuit with no yellow pea hull fibre.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raylene Reimer, PhD, RD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
citation: Lambert JE, Parnell JA, Han J, Sturzenegger T, Paul HA, Vogel HJ, Reimer RA. Evaluation of yellow pea fibre supplementation on weight loss and the gut microbiota: a randomized controlled trial. BMC Gastroenterol. 2014 Apr 8;14:69. doi: 10.1186/1471-230X-14-69.
PMID: 24712378
citation: Lambert JE, Parnell JA, Tunnicliffe JM, Han J, Sturzenegger T, Reimer RA. Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial. Clin Nutr. 2017 Feb;36(1):126-133. doi: 10.1016/j.clnu.2015.12.016. Epub 2016 Jan 11.
PMID: 26811130
citation: Mayengbam S, Lambert JE, Parnell JA, Tunnicliffe JM, Nicolucci AC, Han J, Sturzenegger T, Shearer J, Mickiewicz B, Vogel HJ, Madsen KL, Reimer RA. Impact of dietary fiber supplementation on modulating microbiota-host-metabolic axes in obesity. J Nutr Biochem. 2019 Feb;64:228-236. doi: 10.1016/j.jnutbio.2018.11.003. Epub 2018 Nov 26.
PMID: 30572270
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Raylene Reimer
investigator title: Professor, Faculty of Kinesiology
mesh term: Obesity
mesh term: Metabolic Syndrome
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 