<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/NCT03020758</url>
  </required_header>
  <id_info>
    <org_study_id>PKE DRIED FRUIT</org_study_id>
    <nct_id>NCT03020758</nct_id>
  </id_info>
  <brief_title>Effect of Dried Fruit on Cardiometabolic Risk Factors</brief_title>
  <official_title>The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared With a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Nut and Dried Fruit Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>California Dried Plum Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 2-period randomized crossover study with free-living subjects on self-selected&#xD;
      diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried&#xD;
      plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack&#xD;
      food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who&#xD;
      are representative of the U.S. population and at risk for cardiovascular disease&#xD;
      (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).&#xD;
&#xD;
      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood&#xD;
      pressure and LDL-cholesterol, and improve artery function (assessed by standard blood&#xD;
      pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial&#xD;
      stiffness) compared to the control group and baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL Cholesterol</measure>
    <time_frame>4 weeks</time_frame>
    <description>serum low-density cholesterol concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol, non-HDL cholesterol, triglycerides</measure>
    <time_frame>4 weeks</time_frame>
    <description>serum concentrations of HDL and non-HDL cholesterol and triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central blood pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>central systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>4 weeks</time_frame>
    <description>carotid-femoral pulse wave velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brachial blood pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>brachial systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>4 weeks</time_frame>
    <description>fasting plasma glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-sensitivity C-reactive protein</measure>
    <time_frame>4 weeks</time_frame>
    <description>serum hs-CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>4 weeks</time_frame>
    <description>fasting serum insulin</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fecal Microbiome</measure>
    <time_frame>4 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Dried Fruit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dried Fruit</intervention_name>
    <description>Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.</description>
    <arm_group_label>Dried Fruit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Carbohydrate Snack</intervention_name>
    <description>Calorie-matched carbohydrate-rich snack.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index of 25-36 kg/m2&#xD;
&#xD;
        And, at least one of the following:&#xD;
&#xD;
          -  LDL-C above 116 mg/dL (3.0 mmol/L)&#xD;
&#xD;
          -  Systolic blood pressure 120-159 mmHg&#xD;
&#xD;
          -  Diastolic blood pressure 80-99 mmHg&#xD;
&#xD;
          -  Increased waist circumference: ≥94 cm for men and ≥80 cm for women&#xD;
&#xD;
          -  Elevated glucose (≥ 100 mg/dL and &lt; 126 mg/dL)&#xD;
&#xD;
          -  Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)&#xD;
&#xD;
          -  Low HDL-cholesterol: &lt;40 mg/dL (&lt; 1.03 mmol/L) for men and &lt; 50 mg/dL (&lt;1.29 mmol/L)&#xD;
             for women)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to the test foods&#xD;
&#xD;
          -  History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney&#xD;
             disease, diabetes or inflammatory diseases such as gastrointestinal disorders and&#xD;
             rheumatoid arthritis&#xD;
&#xD;
          -  Use of medication/supplements for elevated lipids, blood pressure, or glucose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Penny Kris-Etherton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT03020758
org study id: PKE DRIED FRUIT
nct id: NCT03020758
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 2-period randomized crossover study with free-living subjects on self-selected
      diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried
      plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack
      food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who
      are representative of the U.S. population and at risk for cardiovascular disease
      (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).

      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood
      pressure and LDL-cholesterol, and improve artery function (assessed by standard blood
      pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial
      stiffness) compared to the control group and baseline.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: LDL Cholesterol
time frame: 4 weeks
description: serum low-density cholesterol concentration
measure: HDL-cholesterol, non-HDL cholesterol, triglycerides
time frame: 4 weeks
description: serum concentrations of HDL and non-HDL cholesterol and triglycerides
measure: Central blood pressure
time frame: 4 weeks
description: central systolic and diastolic blood pressure
measure: Pulse wave velocity
time frame: 4 weeks
description: carotid-femoral pulse wave velocity
measure: Brachial blood pressure
time frame: 4 weeks
description: brachial systolic and diastolic blood pressure
measure: Plasma glucose
time frame: 4 weeks
description: fasting plasma glucose
measure: High-sensitivity C-reactive protein
time frame: 4 weeks
description: serum hs-CRP
measure: Serum insulin
time frame: 4 weeks
description: fasting serum insulin
measure: Fecal Microbiome
time frame: 4 weeks
arm group label: Dried Fruit
arm group type: Experimental
description: Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks
arm group label: Control
arm group type: Experimental
description: Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks
intervention type: Dietary Supplement
intervention name: Dried Fruit
description: Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
arm group label: Dried Fruit
intervention type: Other
intervention name: High Carbohydrate Snack
description: Calorie-matched carbohydrate-rich snack.
arm group label: Control
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Penny Kris-Etherton, PhD
role: Principal Investigator
affiliation: Penn State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Metabolic Syndrome
sharing ipd: No