Liquorice and Salivary Cortisol

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Liquorice on Salivary Cortisol and Cortisone

Conditions
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Cushing Syndrome, Hypercortisolism

Intervention / Treatment
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* Dietary Supplement: Liqourice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glycyrrhizic acid 1.5 mg/kg body weight<br>Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. | Dietary Supplement: Liqourice<br>* 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.<br>* Other names: glycyrrhizic acid;|
| Active Comparator: glycyrrhizic acid 3.0 mg/kg body weight<br>Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. | Dietary Supplement: Liqourice<br>* 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.<br>* Other names: glycyrrhizic acid;|
| Active Comparator: glycyrrhizic acid 6.0 mg/kg body weight<br>Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. | Dietary Supplement: Liqourice<br>* 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.<br>* Other names: glycyrrhizic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |