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CompletedNCT05661721Updated Aug 28, 2023

Licorice and Home Blood Pressure

An interventional study of Sweet licorice and Salty licorice in Hypertension,Essential, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by Linkoeping University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed description

Healthy volunteers will be invited to participate in a randomized, non-blinded, cross-over study. Participants will be randomized to either of two groups with a 1:1 allocation ratio, stratified by sex. Intervention will be sweet licorice and control will be salty licorice. A run-in period of 1 week will be followed by a 2-week intervention/control, a 2-week washout period, another 2-week control/intervention period and again a 2-week washout period. Home blood pressure will be measured continuously, and blood samples (including potassium and aldosterone) will be collected every two weeks. Analyses will be made comparing baseline characteristics of the two groups, intervention/control and washout period results of the two groups to look for potential carry-over effects, and finally comparing intervention and washout period results respectively to the baseline data to look for the effects of licorice.

02

Conditions studied

  • Hypertension,Essential
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's enrollment of 28 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18 to 30 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Other
    Intervention first, control after ("Sweet then salty")

    This arm will be divided into the following periods: Run-in period: 7 days without any licorice intake Intervention period: 14 days with sweet licorice intake First wash-out period: 14 days without any licorice intake Control period: 14 days with salty licorice intake Second wash-out period: 14 days without any licorice intake.

    Other: Sweet licorice · Other: Salty licorice

  • Other
    Control first, intervention after ("Salty then sweet")

    This arm will be divided into the following periods: Run-in period: 7 days without any licorice intake Control period: 14 days with salty licorice intake First wash-out period: 14 days without any licorice intake Intervention period: 14 days with sweet licorice intake Second wash-out period: 14 days without any licorice intake.

    Other: Sweet licorice · Other: Salty licorice

Interventions

  • OtherSweet licorice

    Ecologic, vegan and gluten free, low-sodium sweet licorice pastilles made from Glycyrrhiza glabra, with a manufacturer specified content of 4% sugars, 2% glycyrrhizin and 0.03% salt, will be used as intervention. The exact glycyrrhizin content will be determined before the study begins, and participants will be instructed to consume a daily licorice dose that is equivalent to 100 mg of glycyrrhizin.

    Also known as: Glycyrrhiza glabra

  • OtherSalty licorice

    A vegan and gluten free salty licorice without glycyrrhizin, flavored with ammonium chloride, with a manufacturer specified content of 0% sugars and 0.05% salt, will be used as control. The amount of salty licorice will be the same as for sweet licorice, and thus determined after the glycyrrhizin content analysis of the sweet licorice.

06

What researchers measure

Primary outcomes

  1. Systolic home blood pressure (mmHg)

    Systolic home blood pressure (mmHg)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

  2. Diastolic home blood pressure (mmHg)

    Diastolic home blood pressure (mmHg)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

Secondary outcomes

  1. Body weight (kg)

    Body weight (kg)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

  2. Plasma potassium (mmol/L)

    Plasma potassium (mmol/L)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

  3. Plasma sodium (mmol/L)

    Plasma sodium (mmol/L)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

  4. Plasma renin (mIU/L)

    Plasma renin (mIU/L)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

  5. Serum aldosterone (μmol/L)

    Serum aldosterone (μmol/L)

    Time frame: Mean at the end of 14 days of intervention compared with mean during run-in period

07

Study locations

1 site
  • Cityhälsan Centrum
    Norrköping, Östergötland 60239, Sweden
08

References and documents

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. doi: 10.1097/HJH.0000000000002017. PubMed 30234752 ↗
  • 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. PubMed 31615045 ↗
  • 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. PubMed 34269334 ↗
  • 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. PubMed 2079112 ↗
  • 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. PubMed 27979300 ↗

Individual participant data

Plan to share: Yes — As specified below.

Supporting information: Study protocol, Sap, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05661721
Lead sponsor
Linkoeping University
Responsible party
Peder af Geijerstam (Principal investigator, Linkoeping University) — Principal investigator
First posted
Dec 22, 2022
Start date
Jan 30, 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Aug 28, 2023

Study contacts

Fredrik H Nyström, MD, PhD
study director · Linkoeping University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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