Licorice and Home Blood Pressure, Additional Study

Hypertension,Essential Clinical Trial

Official title:

Licorice and Home Blood Pressure, Additional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019598
• Other study ID #: licorice2023_additional
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Linkoeping University
• Contact: Peder af Geijerstam, MD
• Phone: +460739597426
• Email: peder.af.geijerstam[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 31 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension,Essential

Intervention

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.

Locations

Country	Name	City	State
Sweden	Cityhälsan Centrum	Norrköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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