PrehypertensionNCT05412654
Potassium Supplementation to Reduce Blood Pressure
A study testing High potassium water in people with Prehypertension, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Prehypertension
- What is being tested?
- High potassium water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2022to 1 Dec 2023
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide informed consent
- Between 20 to 64 years old
- English speaking
- Adults who are not receiving antihypertensive pharmacological treatment
- Recent (within 6 months) and latest systolic blood pressure measurement ≥130mmHg and/or diastolic ≥85 mmHg
- Have access to internet and equipment for video calling
- Able to post samples and equipment to OxBCNH
- Physically able to take own body measurements and blood pressure
Who cannot join
- Participation in another research study
- Unable to read and understand the instructions provided in English
- Unable to comply with experimental procedures or not follow testing safety guidelines
- People with cardiovascular conditions: heart attack or stroke within the last 3 months, heart failure of grade II New York Heart Association and more severe, or prolonged QT syndrome, angina, arrhythmia or atrial fibrillation.
- Uncontrolled type 2 diabetes (HbA1c> 9%)
- Type 2 diabetes controlled using exogenous insulin
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- Previous or current diagnosis of diabetes complications such as nephropathy, retinopathy and neuropathy.
- People with type 1 diabetes
- Currently on any medication that may lead to hyperkalemia or fluid retention
- Currently being assessed for diagnosis of hypertension (not receiving treatment for high blood pressure)
- Already on clinician/HCP supervised diet or restricted diet
- They are planning on going away from home (holiday or other) during the 4 week intervention period and will not be able to take water during this time.
- Currently prescribed antihypertensive medications, or have been in the last 6 weeks
- Chronic kidney disease stage 1 (G1A2 or G1A3), 2 (G2A2 or G2A3), 3a, 3b, 4 or 5 based on UKKA (we will ask whether participants have been diagnosed with kidney disease by a clinician based on this criteria)
- They are planning to go on a diet or begin taking supplements containing potassium during the intervention
- Pregnant women (including women suspected of being pregnant) and breast-feeding woman.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes University
Oxford, Oxfordshire, ox30bp
About this study
Official title: Testing the Potential Effect of a Potassium-rich Water Intervention on Blood Pressure in Mild to Moderately Hypertensive Adults: a Double-blind Randomised Controlled Trial
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.
- Conditions
- Prehypertension
- Being tested
- High potassium water, Control low potassium water
- Keywords
- Potassium, Blood pressure, Systolic, Randomised
- Medical subject headings
- Prehypertension, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High potassium waterDietary supplement
High potassium water Potassium 6.2 mg/100ml
Control low potassium waterDietary supplement
Control water Potassium 0.2 mg/100ml
| Study group | Role | What they receive |
|---|---|---|
| High potassium water | Experimental | 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. Receives: Dietary Supplement: High potassium water |
| Low potassium control water | Placebo comparator | 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. Receives: Dietary Supplement: Control low potassium water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Blood pressure will be taken at three time points through out the 4 weeks.
Secondary outcomes (2)
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.
Measured: 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.)
Measured: This survey will be administered on the final visit at week 4 of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Jul 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- Suntory Beverage & Food Limited
- Responsible party
- Principal investigator, Shelly Coe, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412654
- Sponsor's protocol ID
- 221579
- Status last verified
- Apr 2024
- First submitted
- 31 May 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Potential Effect of a Potassium-rich Water Intervention on Blood Pressure in Mild to Moderately Hypertensive Adults: a Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05412654
- Acronym / sponsor ID
- 221579
- Conditions
- Prehypertension
- Keywords
- Potassium, Blood pressure, Systolic, Randomised
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- Suntory Beverage & Food Limited
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Jun 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| High potassium water | Experimental | Dietary Supplement: High potassium waterAll 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. |
| Low potassium control water | Placebo comparator | Dietary Supplement: Control low potassium waterAll 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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing and able to provide informed consent
- Between 20 to 64 years old
- English speaking
- Adults who are not receiving antihypertensive pharmacological treatment
- Recent (within 6 months) and latest systolic blood pressure measurement ≥130mmHg and/or diastolic ≥85 mmHg
Key exclusion criteria (16 listed)
- Participation in another research study
- Unable to read and understand the instructions provided in English
- Unable to comply with experimental procedures or not follow testing safety guidelines
- People with cardiovascular conditions: heart attack or stroke within the last 3 months, heart failure of grade II New York Heart Association and more severe, or prolonged QT syndrome, angina, arrhythmia or atrial fibrillation.
- Uncontrolled type 2 diabetes (HbA1c> 9%)
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 |
|---|---|---|
| High potassium waterHigh potassium water Potassium 6.2 mg/100ml | Dietary supplement | High potassium water |
| Control low potassium waterControl water Potassium 0.2 mg/100ml | Dietary supplement | Low potassium control water |
Primary outcome
Seated home measured systolic blood pressure mm/Hg
Time frame: Blood pressure will be taken at three time points through out the 4 weeks.
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.
2 secondary outcomes
Seated home measured diastolic blood pressure
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
Time frame: This survey will be administered on the final visit at week 4 of the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High potassium water in people with Prehypertension, run by Oxford Brookes University at 1 site in United Kingdom.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 4 Apr 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seated home measured systolic blood pressure mm/Hg (time frame: Blood pressure will be taken at three time points through out the 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2024.