Licorice and Home Blood Pressure, Additional Study

Study Overview
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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.

Official Title
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Licorice and Home Blood Pressure, Additional Study

Conditions
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Hypertension,Essential

Intervention / Treatment
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* Other: Licorice


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 31 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Licorice<br>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<br>* Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic home blood pressure | Systolic home blood pressure | 3 days before interventions and 28 days during intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic home blood pressure | Diastolic home blood pressure | 3 days before interventions and 28 days during intervention | 
| Body weight | Body weight | Day 0, 14 and 28 | 
| Plasma sodium | Plasma sodium | Day 0, 14 and 28 | 
| Plasma potassium | Plasma potassium | Day 0, 14 and 28 | 
| Plasma creatinine | Plasma creatinine | Day 0, 14 and 28 | 
| Plasma N-terminal pro B-type natriuretic peptide | Plasma N-terminal pro B-type natriuretic peptide | Day 0, 14 and 28 | 
| Plasma renin | Plasma renin | Day 0, 14 and 28 | 
| Serum aldosterone | Serum aldosterone | Day 0, 14 and 28 |