<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/NCT04487808</url>
  </required_header>
  <id_info>
    <org_study_id>Pecan</org_study_id>
    <nct_id>NCT04487808</nct_id>
  </id_info>
  <brief_title>Diet Quality, Pecans, and Cardiometabolic Health</brief_title>
  <official_title>Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      A three-period, randomized, crossover controlled feeding trial will be conducted to examine&#xD;
      the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average&#xD;
      American intake, compared to a diet representative of average American intake devoid of nuts,&#xD;
      and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular&#xD;
      health, lipids and lipoproteins, blood pressure, and glycemic control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between&#xD;
      the diet periods. All caloric foods and beverages will be provided. Outcome assessments will&#xD;
      be done at baseline and the end of each diet period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study did not enroll any subjects. It was never started because of the Covid pandemic.&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow mediated dilation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measured by brachial ultrasound and expressed as percent artery dilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessed from fasting blood draw expressed in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol concentrations</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessed from fasting blood draw expressed in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessed from fasting blood draw expressed in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL lipoprotein subclasses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessed from fasting blood draw expressed in nmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL lipoprotein subclasses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessed from fasting blood draw expressed in umol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral systolic and diastolic blood pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central systolic and diastolic blood pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotid-femoral pulse wave velocity</measure>
    <time_frame>4 weeks</time_frame>
    <description>A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augmentation Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting blood glucose assessed by blood draw and expressed in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the composition of the gut microbiota</measure>
    <time_frame>4 weeks</time_frame>
    <description>Abundance measured using 16 s rRNA sequencing</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Average American Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Average American Diet + Pecans</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Diet + Pecans</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High diet quality, measured by Healthy Index-2015 score &gt;95, and includes 2 oz./day of pecans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pecan</intervention_name>
    <description>Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern</description>
    <arm_group_label>Average American Diet + Pecans</arm_group_label>
    <arm_group_label>Healthy Diet + Pecans</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Average American Diet devoid of nuts</intervention_name>
    <description>Diet mimicking usual American intake</description>
    <arm_group_label>Average American Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥25 and ≤40 kg/m2&#xD;
&#xD;
          -  ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm&#xD;
             women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood&#xD;
             pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100&#xD;
             mg/dL) at screening.&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current tobacco use or use within the previous 6 months&#xD;
&#xD;
          -  Diagnosed diabetes or fasting glucose levels &gt; 126 mg/dL at screening&#xD;
&#xD;
          -  Systolic blood pressure &gt;160 mm Hg or diastolic blood pressure &gt; 100 mm Hg at&#xD;
             screening.&#xD;
&#xD;
          -  Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or&#xD;
             antibiotics in the previous month&#xD;
&#xD;
          -  History of a cardiovascular event (heart attack, revascularization, stroke), or heart&#xD;
             failure, liver, kidney, autoimmune diseases or inflammatory conditions such as&#xD;
             gastrointestinal disorders or rheumatoid arthritis&#xD;
&#xD;
          -  Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish&#xD;
             oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of&#xD;
             the study&#xD;
&#xD;
          -  Pregnancy, lactation or planning to become pregnant&#xD;
&#xD;
          -  Consumption of &gt;14 alcoholic drinks/week&#xD;
&#xD;
          -  Intolerance/allergy/sensitivity to foods included in the study menus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</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>
  </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/NCT04487808
org study id: Pecan
nct id: NCT04487808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A three-period, randomized, crossover controlled feeding trial will be conducted to examine
      the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average
      American intake, compared to a diet representative of average American intake devoid of nuts,
      and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular
      health, lipids and lipoproteins, blood pressure, and glycemic control.
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between
      the diet periods. All caloric foods and beverages will be provided. Outcome assessments will
      be done at baseline and the end of each diet period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Flow mediated dilation
time frame: 4 weeks
description: Measured by brachial ultrasound and expressed as percent artery dilation
measure: LDL-cholesterol concentration
time frame: 4 weeks
description: Assessed from fasting blood draw expressed in mg/dL
measure: HDL-cholesterol concentrations
time frame: 4 weeks
description: Assessed from fasting blood draw expressed in mg/dL
measure: Triglycerides
time frame: 4 weeks
description: Assessed from fasting blood draw expressed in mg/dL
measure: LDL lipoprotein subclasses
time frame: 4 weeks
description: Assessed from fasting blood draw expressed in nmol/L
measure: HDL lipoprotein subclasses
time frame: 4 weeks
description: Assessed from fasting blood draw expressed in umol/L
measure: Peripheral systolic and diastolic blood pressure
time frame: 4 weeks
description: Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)
measure: Central systolic and diastolic blood pressure
time frame: 4 weeks
description: Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).
measure: Carotid-femoral pulse wave velocity
time frame: 4 weeks
description: A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.
measure: Augmentation Index
time frame: 4 weeks
description: A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness.
measure: Fasting plasma glucose concentration
time frame: 4 weeks
description: Fasting blood glucose assessed by blood draw and expressed in mg/dL
measure: Serum insulin concentration
time frame: 4 weeks
description: Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL
measure: Change in the composition of the gut microbiota
time frame: 4 weeks
description: Abundance measured using 16 s rRNA sequencing
arm group label: Average American Diet
arm group type: Active Comparator
description: Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.
arm group label: Average American Diet + Pecans
arm group type: Active Comparator
description: Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans.
arm group label: Healthy Diet + Pecans
arm group type: Active Comparator
description: High diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans.
intervention type: Drug
intervention name: Pecan
description: Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern
arm group label: Average American Diet + Pecans
arm group label: Healthy Diet + Pecans
intervention type: Other
intervention name: Average American Diet devoid of nuts
description: Diet mimicking usual American intake
arm group label: Average American Diet
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No