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Liquorice and Salivary Cortisol

Primary Purpose

Cushing Syndrome, Hypercortisolism

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Liqourice

About this trial

This is an interventional diagnostic trial for Cushing Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Public Health and Clinical, Umeå UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

glycyrrhizic acid 1.5 mg/kg body weight

glycyrrhizic acid 3.0 mg/kg body weight

glycyrrhizic acid 6.0 mg/kg body weight

Arm Description

Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Outcomes

Primary Outcome Measures

Late night salivary cortisol

Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).

Time to normalization of late night salivary cortisol

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.

Secondary Outcome Measures

Morning salivary cortisol

Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).

Late night salivary cortisol/cortisone ratio

Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).

Time to normalization of late night salivary cortisol/cortisone ratio

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.

Full Information

NCT ID

NCT04045015

First Posted

August 1, 2019

Last Updated

August 1, 2019

Sponsor

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT04045015

Brief Title

Liquorice and Salivary Cortisol

Official Title

Effects of Liquorice on Salivary Cortisol and Cortisone

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 16, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cushing Syndrome, Hypercortisolism

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Each group of 10 individuals uses liqourice for 7 days and late night salivary cortisol and cortisone is analysed before (baseline), during and after (washout) intake.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

glycyrrhizic acid 1.5 mg/kg body weight

Arm Type

Active Comparator

Arm Description

Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Arm Title

glycyrrhizic acid 3.0 mg/kg body weight

Arm Type

Active Comparator

Arm Description

Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Arm Title

glycyrrhizic acid 6.0 mg/kg body weight

Arm Type

Active Comparator

Arm Description

Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Liqourice

Other Intervention Name(s)

glycyrrhizic acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Late night salivary cortisol

Description

Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).

Time Frame

day 1 to day 7 during liqourice intake

Title

Time to normalization of late night salivary cortisol

Description

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.

Time Frame

1-28 days efter liqourice intake is stopped

Secondary Outcome Measure Information:

Title

Morning salivary cortisol

Description

Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).

Time Frame

day 1-2 during liqourice intake

Title

Late night salivary cortisol/cortisone ratio

Description

Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).

Time Frame

day 1 to day 7 during liqourice intake

Title

Time to normalization of late night salivary cortisol/cortisone ratio

Description

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.

Time Frame

1-28 days efter liqourice intake is stopped

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Per Dahlqvist, MD, PhD

Phone

+46-907853390

per.dahlqvist@umu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Nils Bäcklund, MD

Phone

+46-907850000

nils.backlund@umu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Dahlqvist, MD, PhD

Organizational Affiliation

Umeå University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Public Health and Clinical, Umeå University

City

Umeå

ZIP/Postal Code

901 85

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Per Dahlqvist, MD, PhD

Phone

+46-907853390

per.dahlqvist@umu.se

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26156970

Citation

Nieman LK. Cushing's syndrome: update on signs, symptoms and biochemical screening. Eur J Endocrinol. 2015 Oct;173(4):M33-8. doi: 10.1530/EJE-15-0464. Epub 2015 Jul 8.

Results Reference

result

PubMed Identifier

22890008

Citation

Perogamvros I, Ray DW, Trainer PJ. Regulation of cortisol bioavailability--effects on hormone measurement and action. Nat Rev Endocrinol. 2012 Dec;8(12):717-27. doi: 10.1038/nrendo.2012.134. Epub 2012 Aug 14.

Results Reference

result

PubMed Identifier

8504732

Citation

Whorwood CB, Sheppard MC, Stewart PM. Licorice inhibits 11 beta-hydroxysteroid dehydrogenase messenger ribonucleic acid levels and potentiates glucocorticoid hormone action. Endocrinology. 1993 Jun;132(6):2287-92. doi: 10.1210/endo.132.6.8504732.

Results Reference

result

PubMed Identifier

19783236

Citation

Perogamvros I, Owen LJ, Newell-Price J, Ray DW, Trainer PJ, Keevil BG. Simultaneous measurement of cortisol and cortisone in human saliva using liquid chromatography-tandem mass spectrometry: application in basal and stimulated conditions. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Nov 1;877(29):3771-5. doi: 10.1016/j.jchromb.2009.09.014. Epub 2009 Sep 18.

Results Reference

result

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Liquorice and Salivary Cortisol

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