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Status unknownNCT04045015Updated Aug 5, 2019

Liquorice and Salivary Cortisol

An interventional study of Liqourice in Cushing Syndrome and Hypercortisolism, sponsored by Umeå University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Umeå University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Cushing Syndrome
  • Hypercortisolism
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men and women 18-65 years.

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementLiqourice

    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.

    Also known as: glycyrrhizic acid

05

What researchers measure

Primary outcomes

  1. Late night salivary cortisol

    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

  2. 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.

    Time frame: 1-28 days efter liqourice intake is stopped

Secondary outcomes

  1. Morning salivary cortisol

    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

  2. Late night salivary cortisol/cortisone ratio

    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

  3. 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.

    Time frame: 1-28 days efter liqourice intake is stopped

06

Study locations

1 of 1 sites recruiting
  • Department of Public Health and Clinical, Umeå University
    Umeå, 901 85, Sweden
    Recruiting
07

References and documents

Publications

  • 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. PubMed 26156970 ↗
  • 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. PubMed 22890008 ↗
  • 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. PubMed 8504732 ↗
  • 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. PubMed 19783236 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04045015
Lead sponsor
Umeå University
Responsible party
Per Dahlqvist (MD PhD, Umeå University) — Principal investigator
First posted
Aug 5, 2019
Start date
Oct 16, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Aug 5, 2019

Study contacts

Per Dahlqvist, MD, PhD
Contact
per.dahlqvist@umu.se
+46-907853390
Nils Bäcklund, MD
Contact
nils.backlund@umu.se
+46-907850000
Per Dahlqvist, MD, PhD
principal investigator · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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