Liquorice and Salivary Cortisol

NCT04045015 | Unknown

• 1 other identifier: Liquorice_Saliva_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cushing Syndrome; Hypercortisolism

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Morning salivary cortisol

  day 1-2 during liqourice intake

• Late night salivary cortisol/cortisone ratio

  day 1 to day 7 during liqourice intake

• Time to normalization of late night salivary cortisol/cortisone ratio

  1-28 days efter liqourice intake is stopped

Study Arms (3)

glycyrrhizic acid 1.5 mg/kg body weight

ACTIVE COMPARATOR

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

Dietary Supplement: Liqourice

glycyrrhizic acid 3.0 mg/kg body weight

ACTIVE COMPARATOR

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

Dietary Supplement: Liqourice

glycyrrhizic acid 6.0 mg/kg body weight

ACTIVE COMPARATOR

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

Dietary Supplement: Liqourice

Interventions

Liqourice DIETARY_SUPPLEMENT

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

glycyrrhizic acid 1.5 mg/kg body weight; glycyrrhizic acid 3.0 mg/kg body weight; glycyrrhizic acid 6.0 mg/kg body weight

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-65 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Public Health and Clinical, Umeå University

Umeå, 901 85, Sweden

RECRUITING

Related 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.

  PMID: 26156970 RESULT

• 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.

  PMID: 22890008 RESULT

• 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.

  PMID: 8504732 RESULT

• 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.

  PMID: 19783236 RESULT

MeSH Terms

Conditions

Cushing Syndrome

Interventions

Glycyrrhizic Acid

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Per Dahlqvist, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Dahlqvist, MD, PhD

CONTACT

+46-907853390; per.dahlqvist@umu.se

Nils Bäcklund, MD

CONTACT

+46-907850000; nils.backlund@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: October 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)