Cushing Syndrome, Hypercortisolism
Conditions
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.
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.
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late night salivary cortisol | day 1 to day 7 during liqourice intake | Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake). |
| Time to normalization of late night salivary cortisol | 1-28 days efter liqourice intake is stopped | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morning salivary cortisol | day 1-2 during liqourice intake | Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake). |
| Late night salivary cortisol/cortisone ratio | day 1 to day 7 during liqourice intake | Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake). |
| Time to normalization of late night salivary cortisol/cortisone ratio | 1-28 days efter liqourice intake is stopped | 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. |
Countries
Sweden
Contacts
Primary ContactPer Dahlqvist, MD, PhD
Backup ContactNils Bäcklund, MD
Outcome results
None listed