xml: <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/NCT06019598</url>
    </required_header>
    <id_info>
      <org_study_id>licorice2023_additional</org_study_id>
      <nct_id>NCT06019598</nct_id>
    </id_info>
    <brief_title>Licorice and Home Blood Pressure, Additional Study</brief_title>
    <official_title>Licorice and Home Blood Pressure, Additional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Linkoeping University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Linkoeping University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Out-of-office blood pressure is more strongly associated with cardiovascular risk than office&#xD;
        blood pressure. Licorice is known to raise blood pressure, but no previous studies have&#xD;
        measured the effects on home blood pressure. The aim of this study is to analyze the&#xD;
        association between licorice intake and home blood pressure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For a detailed background, please see Clinical Trials registration number NCT05661721. In&#xD;
        brief, out-of-office blood pressure is more strongly associated with cardiovascular risk than&#xD;
        office blood pressure. Licorice is known to raise blood pressure, but no previous studies&#xD;
        have measured the effects on home blood pressure. In a previous study, the response to&#xD;
        licorice intake varied between participants. The aim of this study is to analyze the response&#xD;
        of the most &quot;licorice sensitive&quot; quartile of participants from the original study to lower&#xD;
        dosages of licorice, corresponding to 20 and 50 milligram och GA daily.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Systolic home blood pressure</measure>
      <time_frame>3 days before interventions and 28 days during intervention</time_frame>
      <description>Systolic home blood pressure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diastolic home blood pressure</measure>
      <time_frame>3 days before interventions and 28 days during intervention</time_frame>
      <description>Diastolic home blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Body weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma sodium</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Plasma sodium</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma potassium</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Plasma potassium</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma creatinine</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Plasma creatinine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma N-terminal pro B-type natriuretic peptide</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Plasma N-terminal pro B-type natriuretic peptide</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma renin</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Plasma renin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum aldosterone</measure>
      <time_frame>Day 0, 14 and 28</time_frame>
      <description>Serum aldosterone</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Hypertension,Essential</condition>
    <arm_group>
      <arm_group_label>Licorice</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 weeks of licorice corresponding to 20 mg of glycyrrhizic acid followed by 2 weeks of licorice corresponding to 50 mg of glycyrrhizic acid.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Licorice</intervention_name>
      <description>Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.</description>
      <arm_group_label>Licorice</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previous participation in the Licorice and home blood pressure study (NCT05661721).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known hypertension, cardiovascular disease, kidney disease, liver disease, hormonal&#xD;
               disease, peanut allergy, eating disorder or headache disease (including tension&#xD;
               headache and migraine)&#xD;
  &#xD;
            -  Known alcohol abuse or drug abuse (including cannabis and anabolic steroids) treatment&#xD;
               with hormonal drugs (including oral contraceptives&#xD;
  &#xD;
            -  Known intolerance to licorice intake.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>31 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fredrik H Nyström, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Linkoeping University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peder af Geijerstam, MD</last_name>
      <phone>+460739597426</phone>
      <email>peder.af.geijerstam@liu.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cityhälsan Centrum</name>
        <address>
          <city>Norrköping</city>
          <state>Östergötland</state>
          <zip>60239</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <reference>
      <citation>Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940. Erratum In: J Hypertens. 2019 Jan;37(1):226.</citation>
      <PMID>30234752</PMID>
    </reference>
    <reference>
      <citation>Deutch MR, Grimm D, Wehland M, Infanger M, Kruger M. Bioactive Candy: Effects of Licorice on the Cardiovascular System. Foods. 2019 Oct 14;8(10):495. doi: 10.3390/foods8100495.</citation>
      <PMID>31615045</PMID>
    </reference>
    <reference>
      <citation>Parati G, Stergiou GS, Bilo G, Kollias A, Pengo M, Ochoa JE, Agarwal R, Asayama K, Asmar R, Burnier M, De La Sierra A, Giannattasio C, Gosse P, Head G, Hoshide S, Imai Y, Kario K, Li Y, Manios E, Mant J, McManus RJ, Mengden T, Mihailidou AS, Muntner P, Myers M, Niiranen T, Ntineri A, O'Brien E, Octavio JA, Ohkubo T, Omboni S, Padfield P, Palatini P, Pellegrini D, Postel-Vinay N, Ramirez AJ, Sharman JE, Shennan A, Silva E, Topouchian J, Torlasco C, Wang JG, Weber MA, Whelton PK, White WB, Mancia G; Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. J Hypertens. 2021 Sep 1;39(9):1742-1767. doi: 10.1097/HJH.0000000000002922.</citation>
      <PMID>34269334</PMID>
    </reference>
    <reference>
      <citation>Spinks EA, Fenwick GR. The determination of glycyrrhizin in selected UK liquorice products. Food Addit Contam. 1990 Nov-Dec;7(6):769-78. doi: 10.1080/02652039009373939.</citation>
      <PMID>2079112</PMID>
    </reference>
    <reference>
      <citation>Rizzato G, Scalabrin E, Radaelli M, Capodaglio G, Piccolo O. A new exploration of licorice metabolome. Food Chem. 2017 Apr 15;221:959-968. doi: 10.1016/j.foodchem.2016.11.068. Epub 2016 Nov 17.</citation>
      <PMID>27979300</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Linkoeping University</investigator_affiliation>
      <investigator_full_name>Peder af Geijerstam</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Essential Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>As specified below.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.</ipd_time_frame>
      <ipd_access_criteria>To be determined on a case by case basis.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019598
  org study id: licorice2023_additional
  nct id: NCT06019598
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Out-of-office blood pressure is more strongly associated with cardiovascular risk than office
        blood pressure. Licorice is known to raise blood pressure, but no previous studies have
        measured the effects on home blood pressure. The aim of this study is to analyze the
        association between licorice intake and home blood pressure.
  For a detailed background, please see Clinical Trials registration number NCT05661721. In
        brief, out-of-office blood pressure is more strongly associated with cardiovascular risk than
        office blood pressure. Licorice is known to raise blood pressure, but no previous studies
        have measured the effects on home blood pressure. In a previous study, the response to
        licorice intake varied between participants. The aim of this study is to analyze the response
        of the most "licorice sensitive" quartile of participants from the original study to lower
        dosages of licorice, corresponding to 20 and 50 milligram och GA daily.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Systolic home blood pressure
  time frame: 3 days before interventions and 28 days during intervention
  description: Systolic home blood pressure
  measure: Diastolic home blood pressure
  time frame: 3 days before interventions and 28 days during intervention
  description: Diastolic home blood pressure
  measure: Body weight
  time frame: Day 0, 14 and 28
  description: Body weight
  measure: Plasma sodium
  time frame: Day 0, 14 and 28
  description: Plasma sodium
  measure: Plasma potassium
  time frame: Day 0, 14 and 28
  description: Plasma potassium
  measure: Plasma creatinine
  time frame: Day 0, 14 and 28
  description: Plasma creatinine
  measure: Plasma N-terminal pro B-type natriuretic peptide
  time frame: Day 0, 14 and 28
  description: Plasma N-terminal pro B-type natriuretic peptide
  measure: Plasma renin
  time frame: Day 0, 14 and 28
  description: Plasma renin
  measure: Serum aldosterone
  time frame: Day 0, 14 and 28
  description: Serum aldosterone
  arm group label: Licorice
  arm group type: Experimental
  description: 2 weeks of licorice corresponding to 20 mg of glycyrrhizic acid followed by 2 weeks of licorice corresponding to 50 mg of glycyrrhizic acid.
  intervention type: Other
  intervention name: Licorice
  description: Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.
  arm group label: Licorice
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 31 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fredrik H Nyström, MD, PhD
  role: Study Director
  affiliation: Linkoeping University
  last name: Peder af Geijerstam, MD
  phone: +460739597426
  email: peder.af.geijerstam@liu.se
  facility: 
  country: Sweden
  citation: Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940. Erratum In: J Hypertens. 2019 Jan;37(1):226.
  PMID: 30234752
  citation: Deutch MR, Grimm D, Wehland M, Infanger M, Kruger M. Bioactive Candy: Effects of Licorice on the Cardiovascular System. Foods. 2019 Oct 14;8(10):495. doi: 10.3390/foods8100495.
  PMID: 31615045
  citation: Parati G, Stergiou GS, Bilo G, Kollias A, Pengo M, Ochoa JE, Agarwal R, Asayama K, Asmar R, Burnier M, De La Sierra A, Giannattasio C, Gosse P, Head G, Hoshide S, Imai Y, Kario K, Li Y, Manios E, Mant J, McManus RJ, Mengden T, Mihailidou AS, Muntner P, Myers M, Niiranen T, Ntineri A, O'Brien E, Octavio JA, Ohkubo T, Omboni S, Padfield P, Palatini P, Pellegrini D, Postel-Vinay N, Ramirez AJ, Sharman JE, Shennan A, Silva E, Topouchian J, Torlasco C, Wang JG, Weber MA, Whelton PK, White WB, Mancia G; Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. J Hypertens. 2021 Sep 1;39(9):1742-1767. doi: 10.1097/HJH.0000000000002922.
  PMID: 34269334
  citation: Spinks EA, Fenwick GR. The determination of glycyrrhizin in selected UK liquorice products. Food Addit Contam. 1990 Nov-Dec;7(6):769-78. doi: 10.1080/02652039009373939.
  PMID: 2079112
  citation: Rizzato G, Scalabrin E, Radaelli M, Capodaglio G, Piccolo O. A new exploration of licorice metabolome. Food Chem. 2017 Apr 15;221:959-968. doi: 10.1016/j.foodchem.2016.11.068. Epub 2016 Nov 17.
  PMID: 27979300
  responsible party type: Principal Investigator
  investigator affiliation: Linkoeping University
  investigator full name: Peder af Geijerstam
  investigator title: Principal investigator
  mesh term: Essential Hypertension
  sharing ipd: Yes
  ipd description: As specified below.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
  ipd access criteria: To be determined on a case by case basis.