Licorice and Home Blood Pressure, Additional Study

Sponsor
Linkoeping University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06019598
Collaborator
(none)
7
1
1
4
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Licorice
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Licorice and Home Blood Pressure, Additional Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Licorice

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

Outcome Measures

Primary Outcome Measures

  1. Systolic home blood pressure [3 days before interventions and 28 days during intervention]

    Systolic home blood pressure

Secondary Outcome Measures

  1. Diastolic home blood pressure [3 days before interventions and 28 days during intervention]

    Diastolic home blood pressure

  2. Body weight [Day 0, 14 and 28]

    Body weight

  3. Plasma sodium [Day 0, 14 and 28]

    Plasma sodium

  4. Plasma potassium [Day 0, 14 and 28]

    Plasma potassium

  5. Plasma creatinine [Day 0, 14 and 28]

    Plasma creatinine

  6. Plasma N-terminal pro B-type natriuretic peptide [Day 0, 14 and 28]

    Plasma N-terminal pro B-type natriuretic peptide

  7. Plasma renin [Day 0, 14 and 28]

    Plasma renin

  8. Serum aldosterone [Day 0, 14 and 28]

    Serum aldosterone

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 31 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cityhälsan Centrum Norrköping Östergötland Sweden 60239

Sponsors and Collaborators

  • Linkoeping University

Investigators

  • Study Director: Fredrik H Nyström, MD, PhD, Linkoeping University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peder af Geijerstam, Principal investigator, Linkoeping University
ClinicalTrials.gov Identifier:
NCT06019598
Other Study ID Numbers:
  • licorice2023_additional
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2023