<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/NCT03265353</url>
  </required_header>
  <id_info>
    <org_study_id>487998-8</org_study_id>
    <nct_id>NCT03265353</nct_id>
  </id_info>
  <brief_title>Vascular Effects of Dietary Potassium</brief_title>
  <official_title>Vascular Effects of Dietary Potassium in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</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>
      The purpose of this study is to determine if dietary potassium can attenuate the deleterious&#xD;
      effects of high sodium on blood vessel function in healthy, salt-resistant participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of&#xD;
      diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have&#xD;
      been implicated as risk factors including high sodium and low potassium diets. Indeed, it is&#xD;
      well known that excess sodium can increase BP while potassium rich diets have BP lowering&#xD;
      properties. While the role of these two nutrients on BP is widely accepted, their impact on&#xD;
      the vasculature has received less attention. Endothelial dysfunction, characterized by&#xD;
      impaired dilation is an important non-traditional risk factor for atherosclerosis. Data in&#xD;
      animal models suggest that salt loading, independent of changes in BP, results in endothelial&#xD;
      dysfunction while evidence is mounting that potassium may be beneficial to vascular health.&#xD;
      Further, potassium may be more effective in the presence of high sodium however the role of&#xD;
      potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has&#xD;
      not been explored. A potential mechanism responsible for sodium induced vascular dysfunction&#xD;
      is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO)&#xD;
      production/ bioavailability. It has been suggested that potassium can counteract sodium's&#xD;
      effect by reducing ROS. The central hypothesis is that potassium can protect against the&#xD;
      deleterious effects of high sodium on the vasculature by reducing oxidative stress and&#xD;
      preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding&#xD;
      study to compare the effects of a high sodium diet (300 mmol) combined with either a high&#xD;
      (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with&#xD;
      moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the&#xD;
      vasculature, conduit artery and microvasculature. These experiments will be performed in&#xD;
      salt-resistant participants to study the vascular effects alone, independent of changes in&#xD;
      BP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2013</start_date>
  <completion_date type="Actual">September 22, 2019</completion_date>
  <primary_completion_date type="Actual">September 22, 2019</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>
    <intervention_model_description>All participants will complete each arm. It is a crossover, randomized design.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conduit artery endothelial-dependent dilation</measure>
    <time_frame>on the 7th day of each diet</time_frame>
    <description>The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD</description>
  </primary_outcome>
  <other_outcome>
    <measure>Arterial Stiffness</measure>
    <time_frame>on 7th day of each diet</time_frame>
    <description>Assessed by carotid to femoral artery pulse wave velocity</description>
  </other_outcome>
  <other_outcome>
    <measure>Wave reflection</measure>
    <time_frame>on 7th day of each diet</time_frame>
    <description>Assessed by augmentation index</description>
  </other_outcome>
  <other_outcome>
    <measure>Endothelial cell expression of oxidative stress marker</measure>
    <time_frame>on the 7th day of each diet</time_frame>
    <description>Assessed in venous endothelial cells from participants.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ambulatory blood pressure</measure>
    <time_frame>7 days</time_frame>
    <description>Assessed by 24 hr ambulatory blood pressure monitoring.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Moderate Potassium/Low Sodium Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Potassium/High Sodium Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Potassium/High Sodium Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate Potassium/Low Sodium Diet</intervention_name>
    <description>7 days of the prescribed diet</description>
    <arm_group_label>Moderate Potassium/Low Sodium Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate Potassium/High Sodium Diet</intervention_name>
    <description>7 days of the prescribed diet</description>
    <arm_group_label>Moderate Potassium/High Sodium Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Potassium/High Sodium Diet</intervention_name>
    <description>7 days of the prescribed diet</description>
    <arm_group_label>High Potassium/High Sodium Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  normal blood pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  history of heart disease&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  obese (BMI ≥30)&#xD;
&#xD;
          -  significant weight changes in the last 6 months&#xD;
&#xD;
          -  use of tobacco products&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  on a special diet (gluten free; vegan)&#xD;
&#xD;
          -  take any medications for the above conditions&#xD;
&#xD;
          -  endurance trained athletes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shannon L Lennon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Delaware</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Potassium</keyword>
  <keyword>Sodium</keyword>
  <keyword>Vascular function</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03265353
org study id: 487998-8
nct id: NCT03265353
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if dietary potassium can attenuate the deleterious
      effects of high sodium on blood vessel function in healthy, salt-resistant participants.
Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of
      diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have
      been implicated as risk factors including high sodium and low potassium diets. Indeed, it is
      well known that excess sodium can increase BP while potassium rich diets have BP lowering
      properties. While the role of these two nutrients on BP is widely accepted, their impact on
      the vasculature has received less attention. Endothelial dysfunction, characterized by
      impaired dilation is an important non-traditional risk factor for atherosclerosis. Data in
      animal models suggest that salt loading, independent of changes in BP, results in endothelial
      dysfunction while evidence is mounting that potassium may be beneficial to vascular health.
      Further, potassium may be more effective in the presence of high sodium however the role of
      potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has
      not been explored. A potential mechanism responsible for sodium induced vascular dysfunction
      is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO)
      production/ bioavailability. It has been suggested that potassium can counteract sodium's
      effect by reducing ROS. The central hypothesis is that potassium can protect against the
      deleterious effects of high sodium on the vasculature by reducing oxidative stress and
      preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding
      study to compare the effects of a high sodium diet (300 mmol) combined with either a high
      (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with
      moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the
      vasculature, conduit artery and microvasculature. These experiments will be performed in
      salt-resistant participants to study the vascular effects alone, independent of changes in
      BP.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: All participants will complete each arm. It is a crossover, randomized design.
primary purpose: Prevention
masking: None (Open Label)
measure: Conduit artery endothelial-dependent dilation
time frame: on the 7th day of each diet
description: The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
measure: Arterial Stiffness
time frame: on 7th day of each diet
description: Assessed by carotid to femoral artery pulse wave velocity
measure: Wave reflection
time frame: on 7th day of each diet
description: Assessed by augmentation index
measure: Endothelial cell expression of oxidative stress marker
time frame: on the 7th day of each diet
description: Assessed in venous endothelial cells from participants.
measure: Ambulatory blood pressure
time frame: 7 days
description: Assessed by 24 hr ambulatory blood pressure monitoring.
arm group label: Moderate Potassium/Low Sodium Diet
arm group type: Other
description: Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet.
arm group label: Moderate Potassium/High Sodium Diet
arm group type: Other
description: Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet.
arm group label: High Potassium/High Sodium Diet
arm group type: Other
description: Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet.
intervention type: Other
intervention name: Moderate Potassium/Low Sodium Diet
description: 7 days of the prescribed diet
arm group label: Moderate Potassium/Low Sodium Diet
intervention type: Other
intervention name: Moderate Potassium/High Sodium Diet
description: 7 days of the prescribed diet
arm group label: Moderate Potassium/High Sodium Diet
intervention type: Other
intervention name: High Potassium/High Sodium Diet
description: 7 days of the prescribed diet
arm group label: High Potassium/High Sodium Diet
criteria: 
gender: All
minimum age: 22 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shannon L Lennon, PhD
role: Principal Investigator
affiliation: University of Delaware
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided