Potassium Supplementation to Reduce Blood Pressure

April 2, 2024 updated by: Shelly Coe, Oxford Brookes University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, ox30bp
        • Oxford Brookes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High potassium water
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
High potassium water Potassium 6.2 mg/100ml
Placebo Comparator: Low potassium control 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
Control water Potassium 0.2 mg/100ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Blood pressure will be taken at three time points through out the 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seated home measured diastolic blood pressure
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.
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.
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.)
This survey will be administered on the final visit at week 4 of the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford Brookes University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Suntory Beverage & Food Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 221579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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