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Licorice and Home Blood Pressure

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sweet licorice
Salty licorice
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension,Essential

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 to 30 years 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

Sites / Locations

  • Cityhälsan Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Systolic home blood pressure (mmHg)
Systolic home blood pressure (mmHg)
Diastolic home blood pressure (mmHg)
Diastolic home blood pressure (mmHg)

Secondary Outcome Measures

Body weight (kg)
Body weight (kg)
Plasma potassium (mmol/L)
Plasma potassium (mmol/L)
Plasma sodium (mmol/L)
Plasma sodium (mmol/L)
Plasma renin (mIU/L)
Plasma renin (mIU/L)
Serum aldosterone (μmol/L)
Serum aldosterone (μmol/L)

Full Information

First Posted
December 12, 2022
Last Updated
August 25, 2023
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT05661721
Brief Title
Licorice and Home Blood Pressure
Official Title
Licorice and Home Blood Pressure: a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention first, control after ("Sweet then salty")
Arm Type
Other
Arm Description
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.
Arm Title
Control first, intervention after ("Salty then sweet")
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sweet licorice
Other Intervention Name(s)
Glycyrrhiza glabra
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Salty licorice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic home blood pressure (mmHg)
Description
Systolic home blood pressure (mmHg)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Title
Diastolic home blood pressure (mmHg)
Description
Diastolic home blood pressure (mmHg)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Secondary Outcome Measure Information:
Title
Body weight (kg)
Description
Body weight (kg)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Title
Plasma potassium (mmol/L)
Description
Plasma potassium (mmol/L)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Title
Plasma sodium (mmol/L)
Description
Plasma sodium (mmol/L)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Title
Plasma renin (mIU/L)
Description
Plasma renin (mIU/L)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period
Title
Serum aldosterone (μmol/L)
Description
Serum aldosterone (μmol/L)
Time Frame
Mean at the end of 14 days of intervention compared with mean during run-in period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 30 years 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik H Nyström, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Cityhälsan Centrum
City
Norrköping
State/Province
Östergötland
ZIP/Postal Code
60239
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30234752
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.
Results Reference
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PubMed Identifier
31615045
Citation
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.
Results Reference
background
PubMed Identifier
34269334
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.
Results Reference
background
PubMed Identifier
2079112
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.
Results Reference
background
PubMed Identifier
27979300
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.
Results Reference
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Licorice and Home Blood Pressure

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