Licorice and Home Blood Pressure, Additional Study
Primary Purpose
Hypertension,Essential
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Licorice
Sponsored by
About this trial
This is an interventional other trial for Hypertension,Essential
Eligibility Criteria
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.
Sites / Locations
- Cityhälsan CentrumRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Licorice
Arm Description
2 weeks of licorice corresponding to 20 mg of glycyrrhizic acid followed by 2 weeks of licorice corresponding to 50 mg of glycyrrhizic acid.
Outcomes
Primary Outcome Measures
Systolic home blood pressure
Systolic home blood pressure
Secondary Outcome Measures
Diastolic home blood pressure
Diastolic home blood pressure
Body weight
Body weight
Plasma sodium
Plasma sodium
Plasma potassium
Plasma potassium
Plasma creatinine
Plasma creatinine
Plasma N-terminal pro B-type natriuretic peptide
Plasma N-terminal pro B-type natriuretic peptide
Plasma renin
Plasma renin
Serum aldosterone
Serum aldosterone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06019598
Brief Title
Licorice and Home Blood Pressure, Additional Study
Official Title
Licorice and Home Blood Pressure, Additional Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
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
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
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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Licorice
Arm Type
Experimental
Arm Description
2 weeks of licorice corresponding to 20 mg of glycyrrhizic acid followed by 2 weeks of licorice corresponding to 50 mg of glycyrrhizic acid.
Intervention Type
Other
Intervention Name(s)
Licorice
Intervention Description
Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.
Primary Outcome Measure Information:
Title
Systolic home blood pressure
Description
Systolic home blood pressure
Time Frame
3 days before interventions and 28 days during intervention
Secondary Outcome Measure Information:
Title
Diastolic home blood pressure
Description
Diastolic home blood pressure
Time Frame
3 days before interventions and 28 days during intervention
Title
Body weight
Description
Body weight
Time Frame
Day 0, 14 and 28
Title
Plasma sodium
Description
Plasma sodium
Time Frame
Day 0, 14 and 28
Title
Plasma potassium
Description
Plasma potassium
Time Frame
Day 0, 14 and 28
Title
Plasma creatinine
Description
Plasma creatinine
Time Frame
Day 0, 14 and 28
Title
Plasma N-terminal pro B-type natriuretic peptide
Description
Plasma N-terminal pro B-type natriuretic peptide
Time Frame
Day 0, 14 and 28
Title
Plasma renin
Description
Plasma renin
Time Frame
Day 0, 14 and 28
Title
Serum aldosterone
Description
Serum aldosterone
Time Frame
Day 0, 14 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peder af Geijerstam, MD
Phone
+460739597426
Email
peder.af.geijerstam@liu.se
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peder af Geijerstam, MD
Email
peder.af.geijerstam@liu.se
First Name & Middle Initial & Last Name & Degree
Peder af Geijerstam, MD
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
background
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, Additional Study
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