Cushing SyndromeNCT04045015
Liquorice and Salivary Cortisol
A study testing Liqourice in people with Cushing Syndrome and Hypercortisolism, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cushing Syndrome, Hypercortisolism
- What is being tested?
- Liqourice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18-65 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Public Health and Clinical, Umeå University
Umeå, 901 85
Per Dahlqvist, MD, PhD, +46-907853390, per.dahlqvist@umu.se
About this study
Official title: Effects of Liquorice on Salivary Cortisol and Cortisone
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.
- Conditions
- Cushing Syndrome, Hypercortisolism
- Being tested
- Liqourice
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiqouriceDietary supplement
Also called glycyrrhizic acid
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.
| Study group | Role | What they receive |
|---|---|---|
| glycyrrhizic acid 1.5 mg/kg body weight | Active comparator | Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. Receives: Dietary Supplement: Liqourice |
| glycyrrhizic acid 3.0 mg/kg body weight | Active comparator | Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. Receives: Dietary Supplement: Liqourice |
| glycyrrhizic acid 6.0 mg/kg body weight | Active comparator | Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. Receives: Dietary Supplement: Liqourice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late night salivary cortisol
Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).
Measured: day 1 to day 7 during liqourice intake
Time to normalization of late night salivary cortisol
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.
Measured: 1-28 days efter liqourice intake is stopped
Secondary outcomes (3)
Morning salivary cortisol
Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake).
Measured: day 1-2 during liqourice intake
Late night salivary cortisol/cortisone ratio
Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).
Measured: day 1 to day 7 during liqourice intake
Time to normalization of late night salivary cortisol/cortisone ratio
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.
Measured: 1-28 days efter liqourice intake is stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start16 Oct 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Dahlqvist, Umeå University
- Investigators
- Per Dahlqvist, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045015
- Sponsor's protocol ID
- Liquorice_Saliva_01
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26156970Perogamvros 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.
PubMed 22890008Whorwood 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.
PubMed 8504732Perogamvros 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.
PubMed 19783236
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liquorice on Salivary Cortisol and Cortisone
- ClinicalTrials.gov ID
- NCT04045015
- Acronym / sponsor ID
- Liquorice_Saliva_01
- Conditions
- Cushing Syndrome, Hypercortisolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| glycyrrhizic acid 1.5 mg/kg body weight | Active comparator | Dietary Supplement: LiqouriceLiqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. |
| glycyrrhizic acid 3.0 mg/kg body weight | Active comparator | Dietary Supplement: LiqouriceLiqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. |
| glycyrrhizic acid 6.0 mg/kg body weight | Active comparator | Dietary Supplement: LiqouriceLiqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women 18-65 years.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiqouriceAlso: glycyrrhizic acidLiqourice corresponding to 1.5, 3.0 or 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days. | Dietary supplement | glycyrrhizic acid 1.5 mg/kg body weight, glycyrrhizic acid 3.0 mg/kg body weight, glycyrrhizic acid 6.0 mg/kg body weight |
Primary outcome
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).
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.
3 secondary outcomes
Morning salivary cortisol
Time frame: day 1-2 during liqourice intake
Late night salivary cortisol/cortisone ratio
Time frame: day 1 to day 7 during liqourice intake
Time to normalization of late night salivary cortisol/cortisone ratio
Time frame: 1-28 days efter liqourice intake is stopped
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Results publication: PubMed 26156970Nieman 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.
- Results publication: PubMed 22890008Perogamvros 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.
- Results publication: PubMed 8504732Whorwood 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.
- Results publication: PubMed 19783236Perogamvros 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Dahlqvist, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liqourice in people with Cushing Syndrome and Hypercortisolism, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per Dahlqvist, MD, PhD (+46-907853390, per.dahlqvist@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late night salivary cortisol (time frame: day 1 to day 7 during liqourice intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045015, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.