An interventional study of High potassium water and Control low potassium water in Prehypertension, sponsored by Oxford Brookes University. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Oxford Brookes University · Not applicable, Interventional, and Treatment
The aim of this study is to conduct a definitive trial to assess the efficacy of consuming 1L/day of water rich in potassium to reduce blood pressure in mild to moderately hypertensive adults. The objective is to assess the potential effect of the intervention on reducing systolic blood pressure. This study will comprise of a 4 week, double-blind, parallel randomised controlled trial. Participants will be adults with systolic blood pressure measurements of 130mmHg or greater. The intervention comprises advice to consume bottled water rich in potassium. The comparator will be regular bottled mineral water.This study will recruit 40 people with elevated systolic blood pressure (≥130mmHg) who are not regularly taking antihypertensive medication.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Oxford Brookes University is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be provided with bottled water for the duration of the 4 week intervention to consume 1L/day. The intervention group will receive high potassium water. Participants will be instructed to consume 1 bottle (500 mL) within 2 hours after waking up and 1 bottle (500 mL) within 2 hours before going to bed (total 1L/day). Participants will continue with the same diet and exercise patterns in their daily life similar to before participating in the study, for the whole length of the intervention.
Dietary Supplement: High potassium water
All participants will be provided with bottled water for the duration of the 4 week intervention to consume 1L/day. The control group will receive regular bottled mineral water. Participants will be instructed to consume 1 bottle (500 mL) within 2 hours after waking up and 1 bottle (500 mL) within 2 hours before going to bed (total 1L/day). Participants will continue with the same diet and exercise patterns in their daily life similar to before participating in the study, for the whole length of the intervention.
Dietary Supplement: Control low potassium water
High potassium water Potassium 6.2 mg/100ml
Control water Potassium 0.2 mg/100ml
Seated home measured systolic blood pressure mm/Hg
Blood pressure will me monitored by the participant at home, after detailed instruction are provided by trained researchers over Zoom. Measurements will be taken in duplicate, in the morning and again in the evening (4 times a day total) and the average values will be taken.
Time frame: Blood pressure will be taken at three time points through out the 4 weeks.
Seated home measured diastolic blood pressure
Blood pressure will me monitored by the participant at home, after detailed instruction are provided by trained researchers over Zoom. Measurements will be taken in duplicate, in the morning and again in the evening (4 times a day total) and the average values will be taken.
Time frame: Blood pressure will be taken at three time points through out the 4 weeks
Qualitative semi-structured, part open ended survey of acceptability of trial and reported barriers
This survey will be designed by the researchers understand the participant experience of the intervention, in order to optimise any future study expansion. This will include things that worked well and those that did not work as well, during the trial (consumption of the water, convenience, appropriateness of outcome measures, burden on daily activities and lifestyle, etc.)
Time frame: This survey will be administered on the final visit at week 4 of the trial.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Oxford Brookes University