Liquorice and Salivary Cortisol

Cushing Syndrome Clinical Trial

Official title:

Effects of Liquorice on Salivary Cortisol and Cortisone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045015
• Other study ID #: Liquorice_Saliva_01
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Umeå University
• Contact: Per Dahlqvist, MD, PhD
• Phone: +46-907853390
• Email: per.dahlqvist[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hypercortisolism

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Public Health and Clinical, Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. Review. — View 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 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late night salivary cortisol	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
Primary	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.	1-28 days efter liqourice intake is stopped
Secondary	Morning salivary cortisol	Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).	day 1-2 during liqourice intake
Secondary	Late night salivary cortisol/cortisone ratio	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
Secondary	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.	1-28 days efter liqourice intake is stopped