<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/NCT01696097</url>
  </required_header>
  <id_info>
    <org_study_id>1112011665</org_study_id>
    <secondary_id>S31 Campbell Lab</secondary_id>
    <nct_id>NCT01696097</nct_id>
  </id_info>
  <brief_title>The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults</brief_title>
  <acronym>S31</acronym>
  <official_title>The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the source of dietary protein (pork or&#xD;
      chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high&#xD;
      blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High blood pressure is a major risk factor for heart disease and stroke and affects 50&#xD;
      million people in the United States. Making healthy food choices, such as those in the DASH&#xD;
      (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure&#xD;
      control in people with high blood pressure. The purpose of this study is to determine if the&#xD;
      source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood&#xD;
      pressure control in adults with high blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>After 6 weeks of following DASH diet</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood lipids</measure>
    <time_frame>After 6 weeks of following DASH diet</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Hypertension</condition>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Dietary Counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DASH diet counseling</intervention_name>
    <description>Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.</description>
    <arm_group_label>Dietary Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  age 40-75&#xD;
&#xD;
          -  BMI 25-40 kg/m2&#xD;
&#xD;
          -  systolic blood pressure 120-160 mm Hg&#xD;
&#xD;
          -  diastolic blood pressure &lt;100 mm Hg&#xD;
&#xD;
          -  non-diabetic, no acute illness&#xD;
&#xD;
          -  not following vigorous exercise program&#xD;
&#xD;
          -  urinary continence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;40 or &gt;75&#xD;
&#xD;
          -  BMI &lt;25 or &gt;40 kg/m2&#xD;
&#xD;
          -  systolic blood pressure &lt;120 or &gt;160 mm Hg&#xD;
&#xD;
          -  diastolic blood pressure &gt;100 mm Hg&#xD;
&#xD;
          -  diabetic, acute illness&#xD;
&#xD;
          -  following vigorous exercise program&#xD;
&#xD;
          -  urinary incontinence&#xD;
&#xD;
          -  current smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne W Campbell, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://dashdiet.org/</url>
    <description>DASH eating plan info</description>
  </link>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>August 13, 2015</last_update_submitted>
  <last_update_submitted_qc>August 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Wayne Campbell</investigator_full_name>
    <investigator_title>Prof. Foods and Nutrition</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT01696097
org study id: 1112011665
secondary id: S31 Campbell Lab
nct id: NCT01696097
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the source of dietary protein (pork or
      chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high
      blood pressure.
High blood pressure is a major risk factor for heart disease and stroke and affects 50
      million people in the United States. Making healthy food choices, such as those in the DASH
      (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure
      control in people with high blood pressure. The purpose of this study is to determine if the
      source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood
      pressure control in adults with high blood pressure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in blood pressure
time frame: After 6 weeks of following DASH diet
measure: Change in blood lipids
time frame: After 6 weeks of following DASH diet
arm group label: Dietary Counseling
arm group type: Other
description: Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure
intervention type: Behavioral
intervention name: DASH diet counseling
description: Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.
arm group label: Dietary Counseling
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wayne W Campbell, Ph. D.
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
url: http://dashdiet.org/
description: DASH eating plan info
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Wayne Campbell
investigator title: Prof. Foods and Nutrition
mesh term: Dyslipidemias