<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/NCT03775720</url>
  </required_header>
  <id_info>
    <org_study_id>SMEC_2017-18_142</org_study_id>
    <nct_id>NCT03775720</nct_id>
  </id_info>
  <brief_title>Disclosure of Genetic Risk for Salt Sensitivity</brief_title>
  <official_title>Does Disclosing Genetic Risk to Salt Sensitivity Increase Compliance to Personalised Dietary Recommendations?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Mary's University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>StMarysUC</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 global burden of cardiovascular disease (CVD) has decreased over the past 10 years.&#xD;
      Nevertheless, the disease still kills one in three people. Hypertension is one of the leading&#xD;
      causes of cardiovascular disease, with salt in the diet being a main contributor. Depending&#xD;
      on an individual's DNA, participants may or may not be salt sensitive. Genotyping individuals&#xD;
      for variants in a salt sensitivity gene (SLC4A5) may identify salt sensitive individuals&#xD;
      which may benefit from a personalised dietary advice to reduce salt intake. Adherence to such&#xD;
      advice can then be assessed which may aid in prevention of hypertension and CVD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Salt sensitivity is a key risk factor for hypertension. However, population decrease in salt&#xD;
      intake is less than optimal. Research suggests genetics-based personalised nutrition can&#xD;
      positively impact health behaviours aiding in the prevention of chronic disease development.&#xD;
      However, the effects of communicating such information are unclear. The aims of this study&#xD;
      will be to analyse the impact of communicating genetic susceptibility to salt sensitivity on&#xD;
      salt intake by assessing dietary salt intake before and after disclosure of genetic risk for&#xD;
      hypertension according to the polymorphism in the SLC4A5. Participants will be normotensive,&#xD;
      aged 18-35 years. All individuals will receive genetics-based personalised nutritional&#xD;
      information. Participants displaying the risk genotype (AA + AC) will be advised to decrease&#xD;
      salt intake to less than 4g/d and non-risk will be advised to adhere to government&#xD;
      recommendations (6g/d). Dietary recall (24hrs) and 24-hour urine collection will be collected&#xD;
      at baseline and four-weeks post-intervention to assess salt intake and excretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary salt intake</measure>
    <time_frame>1 month</time_frame>
    <description>24-hour recall</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Salt-sensitive Hypertension</condition>
  <arm_group>
    <arm_group_label>Low genetic risk group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary advice to maintain salt intake to 6g/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High genetic risk group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary advice to reduce salt intake to 4g/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary advice</intervention_name>
    <description>Based on their genetic risk, participants are given advice to either adhere to general dietary guidelines related to salt intake or to reduce their salt intake to no more than 4 grams per day.</description>
    <arm_group_label>High genetic risk group</arm_group_label>
    <arm_group_label>Low genetic risk group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy males and females, aged 18-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant, CVD events (Angina, myocardial infarction, heart failure) or stage 2,&#xD;
             hypertension, a BMI ≥30kg/m2, or experiencing mental anguish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Leta Pilic</last_name>
    <phone>020 8240 4359</phone>
    <email>leta.pilic@stmarys.ac.uk</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St Mary's University College</investigator_affiliation>
    <investigator_full_name>Kim Wright</investigator_full_name>
    <investigator_title>Research Administrator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03775720
org study id: SMEC_2017-18_142
nct id: NCT03775720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The global burden of cardiovascular disease (CVD) has decreased over the past 10 years.
      Nevertheless, the disease still kills one in three people. Hypertension is one of the leading
      causes of cardiovascular disease, with salt in the diet being a main contributor. Depending
      on an individual's DNA, participants may or may not be salt sensitive. Genotyping individuals
      for variants in a salt sensitivity gene (SLC4A5) may identify salt sensitive individuals
      which may benefit from a personalised dietary advice to reduce salt intake. Adherence to such
      advice can then be assessed which may aid in prevention of hypertension and CVD.
Salt sensitivity is a key risk factor for hypertension. However, population decrease in salt
      intake is less than optimal. Research suggests genetics-based personalised nutrition can
      positively impact health behaviours aiding in the prevention of chronic disease development.
      However, the effects of communicating such information are unclear. The aims of this study
      will be to analyse the impact of communicating genetic susceptibility to salt sensitivity on
      salt intake by assessing dietary salt intake before and after disclosure of genetic risk for
      hypertension according to the polymorphism in the SLC4A5. Participants will be normotensive,
      aged 18-35 years. All individuals will receive genetics-based personalised nutritional
      information. Participants displaying the risk genotype (AA + AC) will be advised to decrease
      salt intake to less than 4g/d and non-risk will be advised to adhere to government
      recommendations (6g/d). Dietary recall (24hrs) and 24-hour urine collection will be collected
      at baseline and four-weeks post-intervention to assess salt intake and excretion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Dietary salt intake
time frame: 1 month
description: 24-hour recall
arm group label: Low genetic risk group
arm group type: Experimental
description: Dietary advice to maintain salt intake to 6g/day
arm group label: High genetic risk group
arm group type: Experimental
description: Dietary advice to reduce salt intake to 4g/day
intervention type: Behavioral
intervention name: Dietary advice
description: Based on their genetic risk, participants are given advice to either adhere to general dietary guidelines related to salt intake or to reduce their salt intake to no more than 4 grams per day.
arm group label: High genetic risk group
arm group label: Low genetic risk group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leta Pilic
phone: 020 8240 4359
email: leta.pilic@stmarys.ac.uk
responsible party type: Principal Investigator
investigator affiliation: St Mary's University College
investigator full name: Kim Wright
investigator title: Research Administrator
mesh term: Hypertension
mesh term: Hypersensitivity
sharing ipd: No