Licorice and Home Blood Pressure, Additional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension,Essential
• Intervention / Treatment: Other: Licorice

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 Type: Interventional
• Enrollment (Estimated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peder af Geijerstam, MD; Phone Number: +460739597426; Email: peder.af.geijerstam@liu.se

Study Locations

• Sweden
  • Östergötland
    • Norrköping, Östergötland, Sweden, 60239
      • Recruiting
      • Cityhälsan Centrum
      • Contact: Peder af Geijerstam, MD; Email: peder.af.geijerstam@liu.se
      • Principal Investigator: Peder af Geijerstam, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic home blood pressure	Systolic home blood pressure	3 days before interventions and 28 days during intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic home blood pressure	Diastolic home blood pressure	3 days before interventions and 28 days during intervention
Body weight	Body weight	Day 0, 14 and 28
Plasma sodium	Plasma sodium	Day 0, 14 and 28
Plasma potassium	Plasma potassium	Day 0, 14 and 28
Plasma creatinine	Plasma creatinine	Day 0, 14 and 28
Plasma N-terminal pro B-type natriuretic peptide	Plasma N-terminal pro B-type natriuretic peptide	Day 0, 14 and 28
Plasma renin	Plasma renin	Day 0, 14 and 28
Serum aldosterone	Serum aldosterone	Day 0, 14 and 28

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Fredrik H Nyström, MD, PhD, Linkoeping University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: licorice2023_additional

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As specified below.
• IPD Sharing Time Frame: After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
• IPD Sharing Access Criteria: To be determined on a case by case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No