<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/NCT02224365</url>
  </required_header>
  <id_info>
    <org_study_id>RF02435</org_study_id>
    <secondary_id>2015.14930</secondary_id>
    <nct_id>NCT02224365</nct_id>
  </id_info>
  <brief_title>The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics</brief_title>
  <official_title>Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Apple Association</agency>
      <agency_class>Other</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 75 g dried apple powder for&#xD;
      twelve weeks will improve arterial stiffness and blood pressure by improving&#xD;
      endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering&#xD;
      biochemical markers associated with cardiovascular risk and glycemic control compared to a&#xD;
      macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with&#xD;
      prediabetes or type 2 diabetes who are overweight or obese will be included in the study.&#xD;
      After a two-week run-in phase, eligible men and women will be randomly assigned to one of two&#xD;
      treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve&#xD;
      weeks. After an initial telephone screening, all participants will be requested to report to&#xD;
      the study site for their first visit. On the first visit (screening), participants will be&#xD;
      provided with verbal and written explanation of the project. They will then be asked to sign&#xD;
      an informed consent form, followed by measuring fasting glucose levels and a medical history&#xD;
      questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be&#xD;
      performed for medical history, medication use, dietary intake, and physical activity.&#xD;
      Qualified participants will be scheduled for their second visit two weeks later (actual&#xD;
      baseline data collection) and randomly assigned to their treatment group. On the second&#xD;
      (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function&#xD;
      will be measured followed by blood draw and urine collection. Anthropometrics will be&#xD;
      measured. Participants will be provided with their assigned treatment and will receive&#xD;
      standard instructions on how to fill out daily diaries for their treatment, and for food and&#xD;
      physical activity records. Blood pressure, vascular function, blood draw, urine collection,&#xD;
      and anthropometric, body composition, diet, and physical activity assessments will be&#xD;
      repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular&#xD;
      measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled&#xD;
      room in the supine position after an overnight fast and 12 hours after the abstinence of&#xD;
      caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial Stiffness</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic Control of Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial-mediated Vasodilation</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring flow-mediated dilation in the brachial artery.</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>Atherogenic Markers</measure>
    <time_frame>12 weeks</time_frame>
    <description>By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Apple</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of 75 g dried apple powder taken in 480 ml per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Apple</intervention_name>
    <description>12 weeks of 75 g dried apple powder taken in 480 ml per day.</description>
    <arm_group_label>Apple</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women (1 to 10 years postmenopausal)&#xD;
&#xD;
          -  Aged 45-65 years&#xD;
&#xD;
          -  Prediabetes or Type 2 Diabetes (Hemoglobin A1c ≥ 5.7%)&#xD;
&#xD;
          -  Overweight or obese (body mass index between 25 and 40 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed cardiovascular disease&#xD;
&#xD;
          -  Uncontrolled hypertension (≥ 160/100 mmHg)&#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;
&#xD;
          -  Consumption of more than two apples per week&#xD;
&#xD;
          -  Body mass index less than 25 or greater than 40 kg/m2)&#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>Arturo Figueroa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Food and Exercise Sciences, 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 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 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>Margaret A. Sitton Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Arterial Stiffness</keyword>
  <keyword>Blood Pressure</keyword>
  <keyword>Endothelial Function</keyword>
  <keyword>Body Composition</keyword>
  <keyword>Glycemic Control</keyword>
  <keyword>Apples</keyword>
  <keyword>Functional Foods</keyword>
  <keyword>Polyphenols</keyword>
  <keyword>Fiber</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02224365
org study id: RF02435
secondary id: 2015.14930
nct id: NCT02224365
lead sponsor: 
collaborator: 
has dmc: No
The hypothesis of this study is that the daily consumption of 75 g dried apple powder for
      twelve weeks will improve arterial stiffness and blood pressure by improving
      endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering
      biochemical markers associated with cardiovascular risk and glycemic control compared to a
      macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with
      prediabetes or type 2 diabetes who are overweight or obese 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) 75 g dried apple powder; or 2) 75 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 fasting glucose levels and a medical history
      questionnaire to confirm prediabetes or type 2 diabetes. 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 6:00-11:00 A.M., blood pressure and vascular function
      will be measured followed by blood draw and urine collection. Anthropometrics will be
      measured. Participants will be provided with their assigned treatment and will receive
      standard instructions on how to fill out daily diaries for their treatment, and for food and
      physical activity records. Blood pressure, vascular function, blood draw, urine collection,
      and anthropometric, body composition, diet, and physical activity assessments will be
      repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular
      measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled
      room in the supine position 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Blood Pressure
time frame: 12 weeks
description: By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
measure: Arterial Stiffness
time frame: 12 weeks
description: By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
measure: Autonomic Control of Blood Pressure
time frame: 12 weeks
description: By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
measure: Endothelial-mediated Vasodilation
time frame: 12 weeks
description: By measuring flow-mediated dilation in the brachial artery.
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: Atherogenic Markers
time frame: 12 weeks
description: By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
measure: Body Composition
time frame: 12 weeks
description: By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
arm group label: Apple
arm group type: Experimental
description: 12 weeks of 75 g dried apple powder taken in 480 ml per day.
arm group label: Placebo
arm group type: Placebo Comparator
description: 12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
intervention type: Dietary Supplement
intervention name: Apple
description: 12 weeks of 75 g dried apple powder taken in 480 ml per day.
arm group label: Apple
intervention type: Dietary Supplement
intervention name: Placebo
description: 12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
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: Arturo Figueroa, MD, PhD
role: Principal Investigator
affiliation: Department of Nutrition, Food and Exercise Sciences, 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: Margaret A. Sitton Professor
mesh term: Cardiovascular Diseases