<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/NCT02217579</url>
  </required_header>
  <id_info>
    <org_study_id>UofC Protocol REB13-0169</org_study_id>
    <nct_id>NCT02217579</nct_id>
  </id_info>
  <brief_title>Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults</brief_title>
  <official_title>Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Mills</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The metabolic syndrome is rising worldwide as a consequence of the continued obesity&#xD;
      epidemic. The current obesogenic environment makes the regulation of energy intake difficult&#xD;
      and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb&#xD;
      hunger and reduce energy intake are critically needed. We hypothesize that inclusion of&#xD;
      protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of our study is to assess the effects of protein and prebiotic fiber&#xD;
      intake on changes in adiposity in an overweight and obese adult population.&#xD;
&#xD;
      Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber&#xD;
      (16 g/day) intake on changes in body composition, chiefly body fat.&#xD;
&#xD;
      Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day)&#xD;
      or prebiotic fiber (16 g/day) intake.&#xD;
&#xD;
      Other outcomes includes changes in quality of life ratings and gut microbiota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline fat mass at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessed with dual energy x-ray absorptiometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline appetite at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in baseline quality of life rating at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured with SF-36 questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline gut microbiota at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by high throughput sequencing</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Isocaloric food without the test protein and prebiotic fiber.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary protein consumed as two daily servings of 5 grams protein/serving.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein plus prebiotic fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein</intervention_name>
    <description>A food containing 5 grams/serving of supplemental protein.</description>
    <arm_group_label>Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prebiotic fiber</intervention_name>
    <description>A food containing 8 grams/serving of supplemental prebiotic fiber.</description>
    <arm_group_label>Fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein plus prebiotic fiber</intervention_name>
    <description>A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).</description>
    <arm_group_label>Protein plus prebiotic fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>An isocaloric food not containing the test protein and fiber.</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;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Clinically significant cardiovascular, liver or pancreas disease&#xD;
&#xD;
          -  Major gastrointestinal surgeries&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Concomitant use of any weight loss medication, diet or exercise regime&#xD;
&#xD;
          -  Antibiotic use in the preceding 3 months to enrollment&#xD;
&#xD;
          -  Weight loss &gt; 3 kg within preceding 3 months to enrollment&#xD;
&#xD;
          -  Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements&#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 A 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>
  <results_reference>
    <citation>Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.</citation>
    <PMID>28730743</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</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</investigator_title>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Appetite</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Dietary fiber</keyword>
  <keyword>Dietary protein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02217579
org study id: UofC Protocol REB13-0169
nct id: NCT02217579
lead sponsor: 
collaborator: 
has dmc: No
The metabolic syndrome is rising worldwide as a consequence of the continued obesity
      epidemic. The current obesogenic environment makes the regulation of energy intake difficult
      and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb
      hunger and reduce energy intake are critically needed. We hypothesize that inclusion of
      protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity
      adults.
The main objective of our study is to assess the effects of protein and prebiotic fiber
      intake on changes in adiposity in an overweight and obese adult population.

      Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber
      (16 g/day) intake on changes in body composition, chiefly body fat.

      Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day)
      or prebiotic fiber (16 g/day) intake.

      Other outcomes includes changes in quality of life ratings and gut microbiota.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in baseline fat mass at 12 weeks
time frame: 12 weeks
description: Assessed with dual energy x-ray absorptiometry.
measure: Change in baseline appetite at 12 weeks
time frame: 12 weeks
description: Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
measure: Change in baseline quality of life rating at 12 weeks
time frame: 12 weeks
description: Measured with SF-36 questionnaire
measure: Change in baseline gut microbiota at 12 weeks
time frame: 12 weeks
description: Measured by high throughput sequencing
arm group label: Control
arm group type: Placebo Comparator
description: Isocaloric food without the test protein and prebiotic fiber.
arm group label: Protein
arm group type: Experimental
description: Dietary protein consumed as two daily servings of 5 grams protein/serving.
arm group label: Fiber
arm group type: Experimental
description: Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
arm group label: Protein plus prebiotic fiber
arm group type: Experimental
description: Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.
intervention type: Dietary Supplement
intervention name: Protein
description: A food containing 5 grams/serving of supplemental protein.
arm group label: Protein
intervention type: Dietary Supplement
intervention name: Prebiotic fiber
description: A food containing 8 grams/serving of supplemental prebiotic fiber.
arm group label: Fiber
intervention type: Dietary Supplement
intervention name: Protein plus prebiotic fiber
description: A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
arm group label: Protein plus prebiotic fiber
intervention type: Dietary Supplement
intervention name: Control
description: An isocaloric food not containing the test protein and fiber.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raylene A Reimer, PhD, RD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
citation: Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.
PMID: 28730743
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Raylene Reimer
investigator title: Professor
mesh term: Overweight
sharing ipd: No