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Potassium Supplementation to Reduce Blood Pressure

Primary Purpose

Prehypertension

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High potassium water
Control low potassium water
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Potassium, Blood pressure, Systolic, Randomised

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oxford Brookes UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High potassium water

Low potassium control water

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.)

Full Information

First Posted
May 31, 2022
Last Updated
September 19, 2022
Sponsor
Oxford Brookes University
Collaborators
Suntory Beverage & Food Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05412654
Brief Title
Potassium Supplementation to Reduce Blood Pressure
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
Suntory Beverage & Food Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Potassium, Blood pressure, Systolic, Randomised

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomised controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High potassium water
Arm Type
Experimental
Arm Description
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.
Arm Title
Low potassium control water
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High potassium water
Intervention Description
High potassium water Potassium 6.2 mg/100ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Control low potassium water
Intervention Description
Control water Potassium 0.2 mg/100ml
Primary Outcome Measure Information:
Title
Seated home measured systolic blood pressure mm/Hg
Description
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.
Secondary Outcome Measure Information:
Title
Seated home measured diastolic blood pressure
Description
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
Title
Qualitative semi-structured, part open ended survey of acceptability of trial and reported barriers
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Coe, PhD
Phone
07531435736
Email
scoe@brookes.ac.uk
Facility Information:
Facility Name
Oxford Brookes University
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
ox30bp
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Coe, PhD
Phone
01865483251
Email
scoe@brookes.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Potassium Supplementation to Reduce Blood Pressure

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