Liquorice and Salivary Cortisol

August 1, 2019 updated by: Per Dahlqvist, Umeå University

Effects of Liquorice on Salivary Cortisol and Cortisone

Salivary cortisol is used as a diagnostic analysis in the investigation of suspected Cushings' syndrome. This study evaluates if liqourice intake increases salivary cortisol in healthy individuals. Late night salivary cortisol and cortisone is analysed before, during and after 7 days of liqourice intake in three different doses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Umeå, Sweden, 901 85
        • Recruiting
        • Department of Public Health and Clinical, Umeå University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18-65 years.

Exclusion Criteria:

  • Known pituitary or adrenal disease
  • Medication with glucocorticoids (incl. inhalation, nasal, dermal)
  • Known hypertension or blood pressure >140/90 at screening
  • tobacco use
  • Subjective problems in oral mucosa or saliva
  • Abnormal diurnal rhythm (awake 03:00 - 05:30)
  • Difficulties taking liqourice for 3 weeks or refraining from liqourice during 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: glycyrrhizic acid 1.5 mg/kg body weight
Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary supplement: Liqourice
Liqourice corresponding to 1.5, 3.0 or 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Other Names:
  • glycyrrhizic acid
Active Comparator: glycyrrhizic acid 3.0 mg/kg body weight
Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary supplement: Liqourice
Liqourice corresponding to 1.5, 3.0 or 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Other Names:
  • glycyrrhizic acid
Active Comparator: glycyrrhizic acid 6.0 mg/kg body weight
Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary supplement: Liqourice
Liqourice corresponding to 1.5, 3.0 or 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Other Names:
  • glycyrrhizic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late night salivary cortisol
Time Frame: day 1 to day 7 during liqourice intake
Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).
day 1 to day 7 during liqourice intake
Time to normalization of late night salivary cortisol
Time Frame: 1-28 days efter liqourice intake is stopped
Time from liqourice intake is stopped until significant increase of late night salivary cortisol from baseline (i.e. assuming outcome 1 is significant increase) is no longer significant.
1-28 days efter liqourice intake is stopped

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning salivary cortisol
Time Frame: day 1-2 during liqourice intake
Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).
day 1-2 during liqourice intake
Late night salivary cortisol/cortisone ratio
Time Frame: day 1 to day 7 during liqourice intake
Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).
day 1 to day 7 during liqourice intake
Time to normalization of late night salivary cortisol/cortisone ratio
Time Frame: 1-28 days efter liqourice intake is stopped
Time from liqourice intake is stopped until significant increase of late night salivary cortisol from baseline (i.e. assuming outcome 1 is significant increase) is no longer significant.
1-28 days efter liqourice intake is stopped

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Per Dahlqvist, MD, PhD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liquorice_Saliva_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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