<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/NCT02228837</url>
  </required_header>
  <id_info>
    <org_study_id>RF02456</org_study_id>
    <nct_id>NCT02228837</nct_id>
  </id_info>
  <brief_title>The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome</brief_title>
  <official_title>The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pear Bureau Northwest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington Tree Fruit Research Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve&#xD;
      weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance,&#xD;
      inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women&#xD;
      between the ages of 45 and 65 who have three of the five features of metabolic syndrome as&#xD;
      defined by the Adult Treatment Panel III will be included in the study. After a two-week&#xD;
      run-in phase, eligible men and women will be randomly assigned to one of two treatment&#xD;
      groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks. After an&#xD;
      initial telephone screening, all participants will be requested to report to the study site&#xD;
      for their first visit. On the first visit (screening), participants will be provided with&#xD;
      verbal and written explanation of the project. They will then be asked to sign an informed&#xD;
      consent form, followed by measuring waist circumference, resting brachial blood pressure,&#xD;
      fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to&#xD;
      confirm metabolic syndrome. Baseline assessments will be performed for medical history,&#xD;
      medication use, dietary intake, and physical activity. Qualified participants will be&#xD;
      scheduled for their second visit two weeks later (actual baseline data collection) and&#xD;
      randomly assigned to their treatment group. On the second (baseline) visit between the hours&#xD;
      of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.&#xD;
      Anthropometrics and body composition will be measured. Questionnaires regarding diet,&#xD;
      physical activity, and gastrointestinal health will be performed. Participants will be&#xD;
      provided with their assigned treatment and will receive standard instructions on how to fill&#xD;
      out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),&#xD;
      and 12-week (final visit) intervals. All assessments and information will be collected after&#xD;
      an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the&#xD;
      last bout of moderate to heavy physical activity. After the initial 12 weeks, participants&#xD;
      will undergo a 4-week washout period in which they will not consume either the intervention&#xD;
      or the placebo. After the 4-week washout period, participants will crossover into the other&#xD;
      group to receive either the intervention or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring brachial blood pressure at rest.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atherogenic Markers</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring lipid profiles and atherogenic risk ratios.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring markers of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative Stress</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring markers of oxidative stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Sensitivity</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Health</measure>
    <time_frame>12 weeks</time_frame>
    <description>By using a validated Seven-Day Bowel Movement Questionnaire and serum levels of short-chain fatty acids.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 weeks of consuming 50 g pear-flavored placebo powder mixed with 480 ml per day (1/2 in the morning and 1/2 in the evening at least 6-8 hours apart).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of consuming 2 medium-sized pears per day (1 in the morning and 1 in the evening at least 6-8 hours apart).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pear</intervention_name>
    <arm_group_label>Pear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  Aged 45-65 years old&#xD;
&#xD;
          -  Three of the following five features at the screening visit:&#xD;
&#xD;
          -  Waist circumference of ≥ 40 inches for men and 35 inches for women&#xD;
&#xD;
          -  Serum triglycerides ≥ 150 mg/dL&#xD;
&#xD;
          -  Serum high density lipoprotein cholesterol levels &lt; 40 mg/dL for men and &lt;50 mg/dL for&#xD;
             women&#xD;
&#xD;
          -  Blood pressure ≥ 130/85 mm Hg&#xD;
&#xD;
          -  Fasting blood glucose level ≥ 110 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking hypoglycemic, antihypertensive or cholesterol-lowering medications&#xD;
&#xD;
          -  Diagnosed cardiovascular disease&#xD;
&#xD;
          -  Uncontrolled hypertension (≥ 160/100 mmHg)&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver&#xD;
             and pancreatic disease&#xD;
&#xD;
          -  Participating in a weight loss program&#xD;
&#xD;
          -  Heavy smokers (&gt; 20 cigarettes per day)&#xD;
&#xD;
          -  Heavy drinkers (&gt; 12 alcoholic drinks per week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahram H. Arjmandi, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah A. Johnson, PhD, RDN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Food Science and Human Nutrition, Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Bahram Arjmandi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02228837
org study id: RF02456
nct id: NCT02228837
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve
      weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance,
      inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women
      between the ages of 45 and 65 who have three of the five features of metabolic syndrome as
      defined by the Adult Treatment Panel III will be included in the study. After a two-week
      run-in phase, eligible men and women will be randomly assigned to one of two treatment
      groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks. After an
      initial telephone screening, all participants will be requested to report to the study site
      for their first visit. On the first visit (screening), participants will be provided with
      verbal and written explanation of the project. They will then be asked to sign an informed
      consent form, followed by measuring waist circumference, resting brachial blood pressure,
      fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to
      confirm metabolic syndrome. Baseline assessments will be performed for medical history,
      medication use, dietary intake, and physical activity. Qualified participants will be
      scheduled for their second visit two weeks later (actual baseline data collection) and
      randomly assigned to their treatment group. On the second (baseline) visit between the hours
      of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.
      Anthropometrics and body composition will be measured. Questionnaires regarding diet,
      physical activity, and gastrointestinal health will be performed. Participants will be
      provided with their assigned treatment and will receive standard instructions on how to fill
      out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),
      and 12-week (final visit) intervals. All assessments and information will be collected after
      an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the
      last bout of moderate to heavy physical activity. After the initial 12 weeks, participants
      will undergo a 4-week washout period in which they will not consume either the intervention
      or the placebo. After the 4-week washout period, participants will crossover into the other
      group to receive either the intervention or placebo.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Pressure
time frame: 12 weeks
description: By measuring brachial blood pressure at rest.
measure: Atherogenic Markers
time frame: 12 weeks
description: By measuring lipid profiles and atherogenic risk ratios.
measure: Inflammation
time frame: 12 weeks
description: By measuring markers of inflammation.
measure: Oxidative Stress
time frame: 12 weeks
description: By measuring markers of oxidative stress.
measure: Insulin Sensitivity
time frame: 12 weeks
description: By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.
measure: Body Composition
time frame: 12 weeks
description: By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
measure: Gastrointestinal Health
time frame: 12 weeks
description: By using a validated Seven-Day Bowel Movement Questionnaire and serum levels of short-chain fatty acids.
arm group label: Placebo
arm group type: Placebo Comparator
description: 12 weeks of consuming 50 g pear-flavored placebo powder mixed with 480 ml per day (1/2 in the morning and 1/2 in the evening at least 6-8 hours apart).
arm group label: Pear
arm group type: Experimental
description: 12 weeks of consuming 2 medium-sized pears per day (1 in the morning and 1 in the evening at least 6-8 hours apart).
intervention type: Dietary Supplement
intervention name: Pear
arm group label: Pear
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bahram H. Arjmandi, PhD, RD
role: Principal Investigator
affiliation: Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
last name: Sarah A. Johnson, PhD, RDN
role: Principal Investigator
affiliation: Department of Food Science and Human Nutrition, Colorado State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Bahram Arjmandi
investigator title: Professor
mesh term: Metabolic Syndrome
mesh term: Syndrome