Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigation Into the Effect of Liquorice Ingestion on the Salivary Cortisol to Cortisone Molar Ratio

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939144
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Brief Summary:

Aldosterone, the major mineralocorticoid hormone and cortisol, the major glucocorticoid hormone are produced in the adrenal gland. Aldosterone binds intracellular mineralocorticoid receptors (MR) in the kidney promoting urinary reabsorption of sodium and water and excretion of potassium and hydrogen ions. Unregulated mineralocorticoid excess may, therefore, lead to high blood pressure due to sodium and water retention and hypokalaemic alkalosis.

Blood concentrations of cortisol which has equal affinity for MR are 1000fold greater than those of aldosterone. Therefore in order not to overwhelm MR, cortisol needs to be inactivated before it binds MR. This is achieved by the enzyme 11-betahydroxysteroid dehydrogenase type 2 (11ßHSD-2) in the kidney which rapidly inactivates cortisol to cortisone (this process allows only aldosterone to bind MR). Reduced activity of 11ßHSD-2 leads to an accumulation of cortisol which binds MR and hence has the effect of aldosterone. Reduced activity of 11ßHSD-2 may be seen in the inherited condition of 'Apparent mineralocorticoid excess (AME)' or in excessive liquorice ingestion. The diagnosis of AME and liquorice toxicity is difficult due to unavailability of diagnostic urine analysis in most general laboratories. Cortisol in the salivary glands, similarly to that in kidneys, is metabolised by 11β-HSD2 to cortisone. It is proposed that increased salivary cortisol/cortisone ratio could offer a simple and convenient diagnostic test for AME and liquorice toxicity and can be used as a surrogate marker of urinary cortisol/cortisone ratio. The advantages of salivary cortisol/cortisone include non-invasiveness making it stress free for the patient, no risk of needle stick injury and ease of collection allowing potential home testing and posting of samples.


Condition or disease Intervention/treatment Phase
Apparent Mineralocorticoid Excess Dietary Supplement: Liquorice Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Investigation Into the Effect of Liquorice Ingestion on the Salivary Cortisol to Cortisone Molar Ratio
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 6, 2017
Actual Study Completion Date : March 6, 2017


Arm Intervention/treatment
Experimental: Liquorice
Participants of the single-arm study will ingest liquorice candy and their blood, saliva and urine samples will be collected. They will be regularly monitored for any potential side effects.
Dietary Supplement: Liquorice
Liquorice ingestion will mimic the inherited condition of 'Apparent mineralocorticoid excess (AME)by showing the effects of the reduced activity of 11ßHSD-2 (which leads to an accumulation of cortisol which binds MR and hence has the effect of aldosterone).




Primary Outcome Measures :
  1. salivary cortisol/cortisone ratio induced by liquorice (glycyrrhetinic acid and its metabolites) ingestion [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal blood pressure without electrolyte abnormalities.
  • Healthy, without any known medical conditions or treatment other than the contraceptive pill.

Exclusion Criteria:

  • Pregnant women.
  • Subjects with learning disability or those lacking mental capacity to give consent.
  • On prescribed and over-the-counter medication and herbal remedies excluding the contraceptive pill.
  • Any known medical condition.
  • Subjects with difficult blood access.
  • Subjects with dental disease.
  • Those using tobacco in any form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939144


Locations
Layout table for location information
United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Rousseau Gama The Royal Wolverhampton NHS Trust

Layout table for additonal information
Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02939144     History of Changes
Other Study ID Numbers: 2016LAB86
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperaldosteronism
Mineralocorticoid Excess Syndrome, Apparent
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cortisone
Anti-Inflammatory Agents