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Completed

NCT Number: NCT06019598

Licorice and Home Blood Pressure, Additional Study

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year–31 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cityhälsan Centrum

Norrköping, Östergötland County, 60239, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Licorice

Other

Ecologic sweet licorice pastilles made from Glycyrrhiza glabra grown in Calabria, Italy, with a GA content of 29.9 ±2.0 mg/g.

Primary outcomes

  1. Systolic home blood pressure

    Time frame: 3 days before interventions and 28 days during intervention

    Systolic home blood pressure

Secondary outcomes

  1. Diastolic home blood pressure

    Time frame: 3 days before interventions and 28 days during intervention

    Diastolic home blood pressure

  2. Body weight

    Time frame: Day 0, 14 and 28

    Body weight

  3. Plasma sodium

    Time frame: Day 0, 14 and 28

    Plasma sodium

  4. Plasma potassium

    Time frame: Day 0, 14 and 28

    Plasma potassium

  5. Plasma creatinine

    Time frame: Day 0, 14 and 28

    Plasma creatinine

  6. Plasma N-terminal pro B-type natriuretic peptide

    Time frame: Day 0, 14 and 28

    Plasma N-terminal pro B-type natriuretic peptide

  7. Plasma renin

    Time frame: Day 0, 14 and 28

    Plasma renin

  8. Serum aldosterone

    Time frame: Day 0, 14 and 28

    Serum aldosterone

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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