Clinical trial NCT05661721: Licorice and Home Blood Pressure
Official title: Licorice and Home Blood Pressure: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-12-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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: 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.

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

Primary outcomes:
measure: Systolic home blood pressure (mmHg)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
measure: Diastolic home blood pressure (mmHg)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
Secondary outcomes:
measure: Body weight (kg)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
measure: Plasma potassium (mmol/L)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
measure: Plasma sodium (mmol/L)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
measure: Plasma renin (mIU/L)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
measure: Serum aldosterone (μmol/L)
timeFrame: Mean at the end of 14 days of intervention compared with mean during run-in period
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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