<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/NCT03798938</url>
  </required_header>
  <id_info>
    <org_study_id>01012019</org_study_id>
    <nct_id>NCT03798938</nct_id>
  </id_info>
  <brief_title>Effects of Plant-Based Diet on Peripheral Arterial Disease</brief_title>
  <official_title>Effects of Plant-Based Diet on Peripheral Arterial Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vascular Institute of Texas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vascular Institute of Texas</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the&#xD;
      leading cause of morbidity and mortality in the investigator's society. Peripheral arterial&#xD;
      disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the&#xD;
      lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been&#xD;
      generally regarded as a disease of developed or affluent countries, recent evidence showed a&#xD;
      progressive rise in the prevalence of CVD in developing countries where an epidemiological&#xD;
      shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has&#xD;
      occurred. Management of CVD, particularly with an emphasis of disease prevention, will&#xD;
      undoubtedly play an increasing vital role in the health care system around the world.&#xD;
&#xD;
      Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity,&#xD;
      represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular&#xD;
      mortality. The ability of arteries to dilate in response to stimuli is a significant&#xD;
      indicator of underlying vascular endothelial function and associated CVD. Factors modulating&#xD;
      vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO)&#xD;
      from the endothelium and vascular compliance. In healthy individuals, a major mechanism&#xD;
      responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium,&#xD;
      resulting in vascular smooth muscle relaxation with subsequent vasodilation.&#xD;
&#xD;
      Vascular endothelial function can be assessed using a non-invasive technique to determine&#xD;
      brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in&#xD;
      brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated&#xD;
      dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular&#xD;
      endothelial dysfunction as well as presence of underlying CVD risk factors and related&#xD;
      diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which&#xD;
      is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular&#xD;
      function. While numerous studies have documented the benefit of dietary intervention in the&#xD;
      reduction of CVD related sequelae, limited data is available regarding whether the beneficial&#xD;
      effect of dietary intervention are reflected in vascular endothelial function. The present&#xD;
      study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular&#xD;
      endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease&#xD;
      (PAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with peripheral arterial disease (PAD) will be included in the study. Inclusion&#xD;
      criteria for PAD included an ankle brachial index (ABI) of 0.90 or less at baseline. Those&#xD;
      with an ABI greater than 0.90 at baseline were eligible if a non-invasive vascular ultrasound&#xD;
      demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or&#xD;
      medical records documented prior revascularization of lower extremities.9 Additionally,&#xD;
      subjects must be willing and able to maintain an on-line food journal using smartphone-based&#xD;
      dietary apps. Once enrolled, all participants underwent baseline evaluation, after which they&#xD;
      were enrolled in either dietary advice for plant-based diet (PBD group) or no specific&#xD;
      dietary advice (control group). The dietary intervention was continued for four months, at&#xD;
      the end of which a follow up evaluation was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">January 10, 2019</start_date>
  <completion_date type="Anticipated">October 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>endothelial function</measure>
    <time_frame>10 minutes</time_frame>
    <description>brachial artery reactivity test, flow-mediated vasodilation</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>plant-based diet</intervention_name>
    <description>subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        peripheral arterial disease as defined by an ankle brachial index (ABI) of 0.90 or less at&#xD;
        baseline. Those with an ABI greater than 0.90 at baseline will be eligible if a&#xD;
        non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed&#xD;
        arterial stenosis of 70% or greater, or medical records documented prior revascularization&#xD;
        of lower extremities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  peripheral arterial disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Vascular Associates</name>
      <address>
        <city>Alhambra</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular 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/NCT03798938
org study id: 01012019
nct id: NCT03798938
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the
      leading cause of morbidity and mortality in the investigator's society. Peripheral arterial
      disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the
      lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been
      generally regarded as a disease of developed or affluent countries, recent evidence showed a
      progressive rise in the prevalence of CVD in developing countries where an epidemiological
      shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has
      occurred. Management of CVD, particularly with an emphasis of disease prevention, will
      undoubtedly play an increasing vital role in the health care system around the world.

      Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity,
      represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular
      mortality. The ability of arteries to dilate in response to stimuli is a significant
      indicator of underlying vascular endothelial function and associated CVD. Factors modulating
      vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO)
      from the endothelium and vascular compliance. In healthy individuals, a major mechanism
      responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium,
      resulting in vascular smooth muscle relaxation with subsequent vasodilation.

      Vascular endothelial function can be assessed using a non-invasive technique to determine
      brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in
      brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated
      dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular
      endothelial dysfunction as well as presence of underlying CVD risk factors and related
      diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which
      is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular
      function. While numerous studies have documented the benefit of dietary intervention in the
      reduction of CVD related sequelae, limited data is available regarding whether the beneficial
      effect of dietary intervention are reflected in vascular endothelial function. The present
      study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular
      endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease
      (PAD).
Patients with peripheral arterial disease (PAD) will be included in the study. Inclusion
      criteria for PAD included an ankle brachial index (ABI) of 0.90 or less at baseline. Those
      with an ABI greater than 0.90 at baseline were eligible if a non-invasive vascular ultrasound
      demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or
      medical records documented prior revascularization of lower extremities.9 Additionally,
      subjects must be willing and able to maintain an on-line food journal using smartphone-based
      dietary apps. Once enrolled, all participants underwent baseline evaluation, after which they
      were enrolled in either dietary advice for plant-based diet (PBD group) or no specific
      dietary advice (control group). The dietary intervention was continued for four months, at
      the end of which a follow up evaluation was performed.
observational model: Cohort
time perspective: Cross-Sectional
measure: endothelial function
time frame: 10 minutes
description: brachial artery reactivity test, flow-mediated vasodilation
intervention type: Other
intervention name: plant-based diet
description: subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No