Liquorice and Salivary Cortisol

Not Applicable

• Conditions: Cushing Syndrome; Hypercortisolism
• Interventions: Dietary Supplement: Liqourice

• Registration Number: NCT04045015
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-05
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
glycyrrhizic acid 1.5 mg/kg body weight	Liqourice	Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
glycyrrhizic acid 6.0 mg/kg body weight	Liqourice	Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
glycyrrhizic acid 3.0 mg/kg body weight	Liqourice	Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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).

Trial Locations

Locations (1)

Department of Public Health and Clinical, Umeå University; 🇸🇪 Umeå, Sweden