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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- salivary cortisol/cortisone ratio induced by liquorice (glycyrrhetinic acid and its metabolites) ingestion [ Time Frame: 4 weeks ]
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
|The Royal Wolverhampton NHS Trust|
|Wolverhampton, West Midlands, United Kingdom, WV10 0QP|
|Principal Investigator:||Rousseau Gama||The Royal Wolverhampton NHS Trust|