Cardiovascular HealthNCT05887622
The Potassium Supplementation Study
A study testing Potassium chloride supplement in people with Cardiovascular Health and Cardiovascular Risk Factor, run by University of Delaware at 1 site in United States.
Trial summary
This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Cardiovascular Risk Factor
- What is being tested?
- Potassium chloride supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- men and women
- 18-45 years of age
- all races/ethnicities
- BMI < 30 kg/m2
- BP < 130/80 mmHg
Who cannot join
- presence of hypertension
- known heart disease
- diabetes
- kidney disease
- cancer
- inflammatory conditions
Show all 12Show fewer
- blood clotting disorders
- pregnancy
- adrenal gland disorder
- history of stomach or intestinal bleeding
- history of kidney stones
- serum potassium outside of the normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions
This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.
Read the detailed description
Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.
- Conditions
- Cardiovascular Health, Cardiovascular Risk Factor
- Being tested
- Potassium chloride supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium chloride supplementDietary supplement
Subjects will receive 64 mmol of KCl on the high potassium/high sodium condition.
PlaceboDietary supplement
Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet
| Study group | Role | What they receive |
|---|---|---|
| Moderate potassium/low sodium | Experimental | Subjects will consume a diet moderation in potassium and low in sodium. Receives: Dietary Supplement: Placebo |
| Moderate potassium/high sodium | Experimental | Subjects will consume a diet moderation in potassium and high in sodium. Receives: Dietary Supplement: Placebo |
| High potassium/high sodium | Experimental | Subjects will consume a diet moderation in potassium and high in sodium. Receives: Dietary Supplement: Potassium chloride supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduit artery endothelial dependent dilation
The difference in flow-mediated dilation (FMD) between the 3 diets
Measured: on day 10 of each diet
Blood pressure reactivity
The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline
Measured: on day 10 of each diet
Superoxide levels
The difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed
Measured: on day 10 of each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all arms in a randomized, crossover design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Lennon, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887622
- Sponsor's protocol ID
- 1465208
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions
- ClinicalTrials.gov ID
- NCT05887622
- Acronym / sponsor ID
- 1465208
- Conditions
- Cardiovascular Health, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jun 2023 (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.
This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.
Detailed description
Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants will complete all arms in a randomized, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Moderate potassium/low sodium | Experimental | Dietary Supplement: PlaceboSubjects will consume a diet moderation in potassium and low in sodium. |
| Moderate potassium/high sodium | Experimental | Dietary Supplement: PlaceboSubjects will consume a diet moderation in potassium and high in sodium. |
| High potassium/high sodium | Experimental | Dietary Supplement: Potassium chloride supplementSubjects will consume a diet moderation in potassium and high in sodium. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- men and women
- 18-45 years of age
- all races/ethnicities
- BMI < 30 kg/m2
- BP < 130/80 mmHg
Key exclusion criteria (12 listed)
- presence of hypertension
- known heart disease
- diabetes
- kidney disease
- cancer
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 |
|---|---|---|
| Potassium chloride supplementSubjects will receive 64 mmol of KCl on the high potassium/high sodium condition. | Dietary supplement | High potassium/high sodium |
| PlaceboSubjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet | Dietary supplement | Moderate potassium/high sodium, Moderate potassium/low sodium |
Primary outcome
Conduit artery endothelial dependent dilation
Time frame: on day 10 of each diet
The difference in flow-mediated dilation (FMD) between the 3 diets
Blood pressure reactivity
Time frame: on day 10 of each diet
The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline
Superoxide levels
Time frame: on day 10 of each diet
The difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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 Potassium chloride supplement in people with Cardiovascular Health and Cardiovascular Risk Factor, run by University of Delaware at 1 site in United States.
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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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 States. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Conduit artery endothelial dependent dilation (time frame: on day 10 of each diet). The study lists 3 primary outcomes in all. 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 5 May 2026.