Liquorice and Salivary Cortisol

NCT ID: NCT04045015

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Cushing Syndrome Hypercortisolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Liqourice

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

Liqourice

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

Liqourice

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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glycyrrhizic acid

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Per Dahlqvist

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per Dahlqvist, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Department of Public Health and Clinical, Umeå University

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Per Dahlqvist, MD, PhD

Role: CONTACT

+46-907853390

Nils Bäcklund, MD

Role: CONTACT

+46-907850000

Facility Contacts

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Per Dahlqvist, MD, PhD

Role: primary

+46-907853390

References

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Nieman LK. Cushing's syndrome: update on signs, symptoms and biochemical screening. Eur J Endocrinol. 2015 Oct;173(4):M33-8. doi: 10.1530/EJE-15-0464. Epub 2015 Jul 8.

Reference Type RESULT
PMID: 26156970 (View on PubMed)

Perogamvros I, Ray DW, Trainer PJ. Regulation of cortisol bioavailability--effects on hormone measurement and action. Nat Rev Endocrinol. 2012 Dec;8(12):717-27. doi: 10.1038/nrendo.2012.134. Epub 2012 Aug 14.

Reference Type RESULT
PMID: 22890008 (View on PubMed)

Whorwood CB, Sheppard MC, Stewart PM. Licorice inhibits 11 beta-hydroxysteroid dehydrogenase messenger ribonucleic acid levels and potentiates glucocorticoid hormone action. Endocrinology. 1993 Jun;132(6):2287-92. doi: 10.1210/endo.132.6.8504732.

Reference Type RESULT
PMID: 8504732 (View on PubMed)

Perogamvros I, Owen LJ, Newell-Price J, Ray DW, Trainer PJ, Keevil BG. Simultaneous measurement of cortisol and cortisone in human saliva using liquid chromatography-tandem mass spectrometry: application in basal and stimulated conditions. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Nov 1;877(29):3771-5. doi: 10.1016/j.jchromb.2009.09.014. Epub 2009 Sep 18.

Reference Type RESULT
PMID: 19783236 (View on PubMed)

Other Identifiers

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Liquorice_Saliva_01

Identifier Type: -

Identifier Source: org_study_id

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