Clinical trial NCT04045015: Liquorice and Salivary Cortisol
Official title: Effects of Liquorice on Salivary Cortisol and Cortisone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cushing Syndrome
Hypercortisolism
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Late night salivary cortisol
timeFrame: day 1 to day 7 during liqourice intake
measure: Time to normalization of late night salivary cortisol
timeFrame: 1-28 days efter liqourice intake is stopped
Secondary outcomes:
measure: Morning salivary cortisol
timeFrame: day 1-2 during liqourice intake
measure: Late night salivary cortisol/cortisone ratio
timeFrame: day 1 to day 7 during liqourice intake
measure: Time to normalization of late night salivary cortisol/cortisone ratio
timeFrame: 1-28 days efter liqourice intake is stopped
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Public Health and Clinical, Umeå University
Study officials:
affiliation: Umeå University
name: Per Dahlqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.