Licorice and Home Blood Pressure, Additional Study

NCT ID: NCT06019598

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2024-08-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension,Essential

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Licorice

Intervention Type OTHER

Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.

Interventions

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Licorice

Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

31 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peder af Geijerstam

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fredrik H Nyström, MD, PhD

Role: STUDY_DIRECTOR

Linkoeping University

Locations

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Cityhälsan Centrum

Norrköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 30234752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31615045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34269334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2079112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27979300 (View on PubMed)

Other Identifiers

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licorice2023_additional

Identifier Type: -

Identifier Source: org_study_id

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