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Licorice and Home Blood Pressure, Additional Study

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ClinicalTrials.gov Identifier: NCT06019598
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Peder af Geijerstam, Linkoeping University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension,Essential Other: Licorice Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Licorice and Home Blood Pressure, Additional Study
Actual Study Start Date : September 10, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Glycyrrhiza

Arms and Interventions
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Arm Intervention/treatment
Experimental: Licorice
2 weeks of licorice corresponding to 20 mg of glycyrrhizic acid followed by 2 weeks of licorice corresponding to 50 mg of glycyrrhizic acid.
 Other: Licorice
Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.


Outcome Measures
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Primary Outcome Measures :
  1. Systolic home blood pressure [ Time Frame: 3 days before interventions and 28 days during intervention ]
    Systolic home blood pressure


Secondary Outcome Measures :
  1. Diastolic home blood pressure [ Time Frame: 3 days before interventions and 28 days during intervention ]
    Diastolic home blood pressure

  2. Body weight [ Time Frame: Day 0, 14 and 28 ]
    Body weight

  3. Plasma sodium [ Time Frame: Day 0, 14 and 28 ]
    Plasma sodium

  4. Plasma potassium [ Time Frame: Day 0, 14 and 28 ]
    Plasma potassium

  5. Plasma creatinine [ Time Frame: Day 0, 14 and 28 ]
    Plasma creatinine

  6. Plasma N-terminal pro B-type natriuretic peptide [ Time Frame: Day 0, 14 and 28 ]
    Plasma N-terminal pro B-type natriuretic peptide

  7. Plasma renin [ Time Frame: Day 0, 14 and 28 ]
    Plasma renin

  8. Serum aldosterone [ Time Frame: Day 0, 14 and 28 ]
    Serum aldosterone


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 31 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Previous participation in the Licorice and home blood pressure study (NCT05661721).

Exclusion Criteria:

  • Known hypertension, cardiovascular disease, kidney disease, liver disease, hormonal disease, peanut allergy, eating disorder or headache disease (including tension headache and migraine)
  • Known alcohol abuse or drug abuse (including cannabis and anabolic steroids) treatment with hormonal drugs (including oral contraceptives
  • Known intolerance to licorice intake.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019598


Contacts
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Contact: Peder af Geijerstam, MD +460739597426 peder.af.geijerstam@liu.se

Locations
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Sweden
Cityhälsan Centrum Recruiting
Norrköping, Östergötland, Sweden, 60239
Contact: Peder af Geijerstam, MD       peder.af.geijerstam@liu.se   
Principal Investigator: Peder af Geijerstam, MD         
Sponsors and Collaborators
Linkoeping University
Investigators
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Study Director: Fredrik H Nyström, MD, PhD Linkoeping University
More Information
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Publications:
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.
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.

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Responsible Party: Peder af Geijerstam, Principal investigator, Linkoeping University
ClinicalTrials.gov Identifier: NCT06019598    
Other Study ID Numbers: licorice2023_additional
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As specified below.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
Access Criteria: To be determined on a case by case basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Essential Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases