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CompletedNCT06019598Updated Oct 9, 2024

Licorice and Home Blood Pressure, Additional Study

An interventional study of Licorice in Hypertension,Essential, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 31 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 31 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

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.

02

Conditions studied

  • Hypertension,Essential
03

In context

Essential Hypertension

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

This study's enrollment of 3 is below the median of 166 across 458 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Linkoeping University is the lead sponsor of 193 studies on the registry; 41 are open to participants now.

Browse Linkoeping University studies →

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

04

Who can participate

Ages eligible
18 Years to 31 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • OtherLicorice

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

06

What researchers measure

Primary outcomes

  1. Systolic home blood pressure

    Systolic home blood pressure

    Time frame: 3 days before interventions and 28 days during intervention

Secondary outcomes

  1. Diastolic home blood pressure

    Diastolic home blood pressure

    Time frame: 3 days before interventions and 28 days during intervention

  2. Body weight

    Body weight

    Time frame: Day 0, 14 and 28

  3. Plasma sodium

    Plasma sodium

    Time frame: Day 0, 14 and 28

  4. Plasma potassium

    Plasma potassium

    Time frame: Day 0, 14 and 28

  5. Plasma creatinine

    Plasma creatinine

    Time frame: Day 0, 14 and 28

  6. Plasma N-terminal pro B-type natriuretic peptide

    Plasma N-terminal pro B-type natriuretic peptide

    Time frame: Day 0, 14 and 28

  7. Plasma renin

    Plasma renin

    Time frame: Day 0, 14 and 28

  8. Serum aldosterone

    Serum aldosterone

    Time frame: Day 0, 14 and 28

07

Study locations

1 site
  • Cityhälsan Centrum
    Norrköping, Östergötland County 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. 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, Statistical analysis plan, Informed consent form, 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Feb 2024, 5 months.

Of 69 non-industry interventional studies with no phase under Essential Hypertension, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 47. This study's 5 months is below that.

Counting every sponsor, half of 79 studies reached it within 23 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2023
First posted
Aug 31, 2023
StartActual
Sep 19, 2023
Primary completionActual
Feb 24, 2024
CompletionActual
Aug 13, 2024
Last update
Oct 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06019598
Lead sponsor
Linkoeping University
Responsible party
Peder af Geijerstam (Principal investigator, Linkoeping University) — Principal investigator
First posted
Aug 31, 2023
Start date
Sep 19, 2023
Primary completion
Feb 24, 2024
Completion
Aug 13, 2024
Last update
Oct 9, 2024

Study contacts

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

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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