Clinical trial NCT06019598: Licorice and Home Blood Pressure, Additional Study
Official title: Licorice and Home Blood Pressure, Additional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-08-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Systolic home blood pressure
timeFrame: 3 days before interventions and 28 days during intervention
Secondary outcomes:
measure: Diastolic home blood pressure
timeFrame: 3 days before interventions and 28 days during intervention
measure: Body weight
timeFrame: Day 0, 14 and 28
measure: Plasma sodium
timeFrame: Day 0, 14 and 28
measure: Plasma potassium
timeFrame: Day 0, 14 and 28
measure: Plasma creatinine
timeFrame: Day 0, 14 and 28
measure: Plasma N-terminal pro B-type natriuretic peptide
timeFrame: Day 0, 14 and 28
measure: Plasma renin
timeFrame: Day 0, 14 and 28
measure: Serum aldosterone
timeFrame: Day 0, 14 and 28
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Cityhälsan Centrum
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Fredrik H Nyström, MD, PhD
role: STUDY_DIRECTOR
References:
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