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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04045015
Other study ID # Liquorice_Saliva_01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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