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Liquorice and Salivary Cortisol

Sponsor
Umeå University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04045015
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
26.5
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Liqourice
 N/A

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Oct 16, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • glycyrrhizic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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

    1. 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).

    2. 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).

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Public Health and Clinical, Umeå University Umeå Sweden 901 85

    Sponsors and Collaborators

    • Umeå University

    Investigators

    • Principal Investigator: Per Dahlqvist, MD, PhD, Umeå University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Per Dahlqvist, MD PhD, Umeå University
    ClinicalTrials.gov Identifier:
    NCT04045015
    Other Study ID Numbers:
    • Liquorice_Saliva_01
    First Posted:
    Aug 5, 2019
    Last Update Posted:
    Aug 5, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cushing Syndrome
    Adrenocortical Hyperfunction
    Glycyrrhizic Acid

    Study Results

    No Results Posted as of Aug 5, 2019