Licorice and Home Blood Pressure

Linköping University (LiU)

Status: Completed

Conditions: Hypertension,Essential

Treatments: Other: Sweet licorice; Other: Salty licorice

Study type: Interventional

Funder types: Other

Identifiers

NCT05661721

licorice2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

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

Other group

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.

Treatment:

Other: Sweet licorice

Other: Salty licorice

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

Other group

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.

Treatment:

Other: Sweet licorice

Other: Salty licorice