icorice Influences on cortisol/cortisone, electrolytes and blood pressure

Completed

Conditions: bloeddruk, elektrolyten, cortison/cortisol balans
High bloodpressure
hypertension

Registration Number: NL-OMON46407

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Willing and able to participate in the study protocol
- Written informed consent
- Age 18-60 years
- Office diastolic blood pressure maximal 90 mmHg and office systolic blood pressure maximal 140 mmHg
- BMI > 18 or < 35 g/m2
- No use of medication which affects the primary or secondary outcome measurements such as diuretics, antihypertensive drugs and NSAIDs < six weeks before start of the study
- Willing to adhere to the study protocol
- Accessible veins on arm(s) as determined by examination at information meetings

Exclusion Criteria

- Allergy to one of the ingredients of licorice
- Office blood pressure >140/90 mm
- Reported alcohol consumption > 28 units/week or recreational drug use
- Existing cardiovascular diseases
- Use of medication which affects the primary or secondary outcome measurements such as diuretics, antihypertensive drugs and NSAIDs < six weeks before start of the study
- Currently on a medically prescribed diet, or slimming diet
- Potassium <3.5 mmol/l
- eGFR <60
- Excessive ingestion of licorice (>200 gr/week) or >3 litre of licorice tea per week
- Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the difference in 24-hour ambulatory systolic and<br /><br>diastolic blood pressure after exposure to a fixed dose of licorice</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters will be the difference in cortisol/cortisone<br /><br>ratio, potassium, sodium and aldosterone excretion in 24h urine collection.<br /><br>Furthermore, the difference in concentrations of plasma potassium, sodium,<br /><br>eGFR, creatinine, aldosterone and plasma renin activity will be measured. In<br /><br>addition, we will determine the individual weight at the end of the run-in<br /><br>period (screening) and at the end of the intervention period. Finally, an<br /><br>exploratory analysis for single nucleotide polymorphisms in the gene encoding<br /><br>for 11-beta-hydroxysteroiddehydrogenase will be performed in those five<br /><br>participants with the greatest increase in blood pressure</p><br>