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Liquorice and Salivary Cortisol

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ClinicalTrials.gov Identifier: NCT04045015
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Per Dahlqvist, 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.

Condition or disease Intervention/treatment Phase
Cushing Syndrome Hypercortisolism Dietary Supplement: Liqourice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Liquorice on Salivary Cortisol and Cortisone
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: glycyrrhizic acid 1.5 mg/kg body weight
Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary Supplement: Liqourice
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.
Other Name: glycyrrhizic acid

Active Comparator: glycyrrhizic acid 3.0 mg/kg body weight
Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary Supplement: Liqourice
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.
Other Name: glycyrrhizic acid

Active Comparator: glycyrrhizic acid 6.0 mg/kg body weight
Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
Dietary Supplement: Liqourice
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.
Other Name: glycyrrhizic acid




Primary Outcome Measures :
  1. Late night salivary cortisol [ Time Frame: 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).

  2. Time to normalization of late night salivary cortisol [ Time Frame: 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 :
  1. Morning salivary cortisol [ Time Frame: day 1-2 during liqourice intake ]
    Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).

  2. Late night salivary cortisol/cortisone ratio [ Time Frame: 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).

  3. Time to normalization of late night salivary cortisol/cortisone ratio [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04045015


Contacts
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Contact: Per Dahlqvist, MD, PhD +46-907853390 per.dahlqvist@umu.se
Contact: Nils Bäcklund, MD +46-907850000 nils.backlund@umu.se

Locations
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Sweden
Department of Public Health and Clinical, Umeå University Recruiting
Umeå, Sweden, 901 85
Contact: Per Dahlqvist, MD, PhD    +46-907853390    per.dahlqvist@umu.se   
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Per Dahlqvist, MD, PhD Umeå University

Publications of Results:
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Responsible Party: Per Dahlqvist, MD PhD, Umeå University
ClinicalTrials.gov Identifier: NCT04045015     History of Changes
Other Study ID Numbers: Liquorice_Saliva_01
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Glycyrrhizic Acid
Anti-Inflammatory Agents