No registrations found.
ID
Source
Brief title
Health condition
Hypertension, Licorice, Pseudohyperaldosteronism, Hypokalemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Systolic daytime ambulatory blood pressure
Secondary outcome
- Diastolic daytime ambulatory blood pressure, systolic and diastolic night-time blood pressure and systolic and diastolic 24-hour ambulatory blood pressure
- Cortisol/cortisone ratio, potassium, sodium and aldosterone excretion in 24h urine collection
- Concentrations of plasma potassium, sodium, eGFR, creatinine, aldosterone and plasma renin activity
- Individual susceptibility, participants with significant changes will be considered by investigating the existence of genetic single nucleotide polymorphisms
- Heart rate (daytime, night-time and 24 hour)
- Changes in body weight
Background summary
Licorice contains glycyrrhizic acid, which is known to induce pseudohyperaldosteronism. Glycyrrhizic acid inhibits 11 beta hydroxylase activity and thereby reduces the selective conversion of cortisol to cortisone. Cortisol has a much higher affinity for the mineralocorticoid receptor compared to cortisone and causes activation of the
mineralocorticoid receptors, resulting in hypertension, increased sodium retention, excessive renal potassium loss, low renin and reduced aldosterone levels. There is no worldwide consensus of the legal upper use limit specified for the maximum amount of glycyrrhizic acid that may be present in foods and supplements. The European Food Safety Authority (EFSA) determine a maximum level of glycyrrhizic acid in confectionery of 1500 mg/kg. However, this amount is often exceeded by manufacturers. A maximal level of 100 mg/person/day glycyrrhizic acid ingestion in adults is considered to be safe for the majority of the population, but many individuals exceed the recommended amount. Licorice induced hypertension has been focus of a few studies, but the individual susceptibility to licorice exposure and variations in blood pressure and urinary excretion of cortisol/cortisone ratio has not been systematically assessed
Study objective
Licorice consumption leads to an increase in blood pressure that is associated with alterations in the cortisol/cortisone balance.
Study design
Day 0: Visit 1: Screening
Day 14: Visit 2: Blood sampling, attaching ABPM, start urine collection, weight measurement
Day 15: Visit 3: Handing in ABPM and 24 hour urine collection
Day 22: Visit 4: Blood sampling, attaching ABPM, start urine collection, weight measurement
Day 23: Visit 5: Handing in ABPM and 24 hour urine collection
Intervention
Licorice with an amount of 300 mg glycyrrhizic acid a day for seven (7) days
Departments of Internal & Vascular Medicine; Academic Medical Center (AMC); University of Amsterdam; Meibergdreef 9, Room F4-109;
Amsterdam 1105 AZ
The Netherlands
+31 20 566 5956 / +31 20 566 9111/58070
b.j.vandenborn@amc.nl
Departments of Internal & Vascular Medicine; Academic Medical Center (AMC); University of Amsterdam; Meibergdreef 9, Room F4-109;
Amsterdam 1105 AZ
The Netherlands
+31 20 566 5956 / +31 20 566 9111/58070
b.j.vandenborn@amc.nl
Inclusion criteria
- Willing and able to participate in the study protocol
- Written informed consent
- Age 18-60 years
- BMI > 18 or < 35 g/m2
- 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 mmHg
- 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 for at least six weeks before
start of the study
- Currently on a medically prescribed diet, or slimming diet
- Potassium <3.5 mmol/l
- eGFR <60 mL/min/1.73 m2
- Excessive ingestion of licorice (>200 gr/week) or >3 litre of licorice tea per week
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6991 |
| NTR-old | NTR7181 |
| CCMO | NL64405.018.17 |
| OMON | NL-OMON46407 |