Cardiovascular Risk FactorNCT04101188
Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans
A study testing Moderate Potassium/Low Sodium Diet, Moderate Potassium/High Sodium Diet and High Potassium/High Sodium Diet in people with Cardiovascular Risk Factor, run by University of Delaware at 1 site in United States.
Trial summary
Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Moderate Potassium/Low Sodium Diet, Moderate Potassium/High Sodium Diet and High Potassium/High Sodium Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 31 Jul 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
- healthy
- normal blood pressure
- normal resting ECG
Who cannot join
- hypertension
- history of heart disease
- diabetes
- kidney disease
- obese (BMI ≥30)
- significant weight changes in the last 6 months
Show all 11Show fewer
- use of tobacco products
- pregnant
- on a special diet (gluten free; vegan)
- take any medications for the above conditions
- endurance trained athletes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19716
Shannon L Lennon, PHD, 302-831-2798, slennon@udel.edu
About this study
Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.
Read the detailed description
Significant public health efforts have been made towards salt reduction but most have met with failure. Dietary factors such high sodium/low potassium diets contribute to the development of cardiovascular diseases (CVDs) such as atherosclerosis and high blood pressure (BP). This is important as CVD is the number one killer in the U.S. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation, is an important non-traditional risk factor for atherosclerosis. Evidence supporting potassium's beneficial role on vascular health remains unclear although it may be more effective in the presence of a high sodium diet. A purported mechanism responsible for sodium-induced vascular dysfunction is overproduction of reactive oxygen species (ROS) resulting in reduced nitric oxide (NO) production/bioavailability. Additionally, high sodium diets have been shown to stiffen the endothelium. This investigation will evaluate the vascular effects of dietary potassium during a high salt diet including its impact on sodium-induced oxidative stress and endothelial cell stiffness.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Moderate Potassium/Low Sodium Diet, Moderate Potassium/High Sodium Diet, High Potassium/High Sodium Diet
- Keywords
- Dietary Potassium, Dietary Sodium, Vascular Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Potassium/Low Sodium DietOther
Consumption of 10 days of a diet moderate in potassium and low in sodium.
Moderate Potassium/High Sodium DietOther
Consumption of 10 days of a diet moderate in potassium and high in sodium.
High Potassium/High Sodium DietOther
Consumption of 10 days of a diet high in potassium and high in sodium.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Potassium/Low Sodium | Experimental | Subjects will be provided with a diet that is moderate in potassium and low in sodium. Receives: Other: Moderate Potassium/Low Sodium Diet |
| Moderate Potassium/High Sodium | Experimental | Subjects will be provided with a diet that is moderate in potassium and high in sodium. Receives: Other: Moderate Potassium/High Sodium Diet |
| High Potassium/High Sodium | Experimental | Subjects will be provided with a diet that is high in both potassium and sodium. Receives: Other: High Potassium/High Sodium Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduit artery endothelial-dependent dilation
The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
Measured: on day 10 of the diet
Microvascular function
Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Measured: on day 10 of the diet
Secondary outcomes (1)
Ambulatory BP monitoring
assessed by 24-hour ambulatory blood pressure
Measured: on day 7 and 10 of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Jan 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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 each arm. It is a crossover, randomized design.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Shannon L Lennon, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101188
- Sponsor's protocol ID
- 1472577
- Other IDs
- 5R01HL145055-05
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans
- ClinicalTrials.gov ID
- NCT04101188
- Acronym / sponsor ID
- 1472577
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Dietary Potassium, Dietary Sodium, Vascular Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Sep 2019 (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.
Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.
Detailed description
Significant public health efforts have been made towards salt reduction but most have met with failure. Dietary factors such high sodium/low potassium diets contribute to the development of cardiovascular diseases (CVDs) such as atherosclerosis and high blood pressure (BP). This is important as CVD is the number one killer in the U.S. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation, is an important non-traditional risk factor for atherosclerosis. Evidence supporting potassium's beneficial role on vascular health remains unclear although it may be more effective in the presence of a high sodium diet. A purported mechanism responsible for sodium-induced vascular dysfunction is overproduction of reactive oxygen species (ROS) resulting in reduced nitric oxide (NO) production/bioavailability. Additionally, high sodium diets have been shown to stiffen the endothelium. This investigation will evaluate the vascular effects of dietary potassium during a high salt diet including its impact on sodium-induced oxidative stress and endothelial cell stiffness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will complete each arm. It is a crossover, randomized design.
| Arm | Type | Receives |
|---|---|---|
| Moderate Potassium/Low Sodium | Experimental | Other: Moderate Potassium/Low Sodium DietSubjects will be provided with a diet that is moderate in potassium and low in sodium. |
| Moderate Potassium/High Sodium | Experimental | Other: Moderate Potassium/High Sodium DietSubjects will be provided with a diet that is moderate in potassium and high in sodium. |
| High Potassium/High Sodium | Experimental | Other: High Potassium/High Sodium DietSubjects will be provided with a diet that is high in both potassium and sodium. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- normal blood pressure
- normal resting ECG
Key exclusion criteria (11 listed)
- hypertension
- history of heart disease
- diabetes
- kidney disease
- obese (BMI ≥30)
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 |
|---|---|---|
| Moderate Potassium/Low Sodium DietConsumption of 10 days of a diet moderate in potassium and low in sodium. | Other | Moderate Potassium/Low Sodium |
| Moderate Potassium/High Sodium DietConsumption of 10 days of a diet moderate in potassium and high in sodium. | Other | Moderate Potassium/High Sodium |
| High Potassium/High Sodium DietConsumption of 10 days of a diet high in potassium and high in sodium. | Other | High Potassium/High Sodium |
Primary outcome
Conduit artery endothelial-dependent dilation
Time frame: on day 10 of the diet
The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
Microvascular function
Time frame: on day 10 of the diet
Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
1 secondary outcome
Ambulatory BP monitoring
Time frame: on day 7 and 10 of diet
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 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shannon L Lennon, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Potassium/Low Sodium Diet, Moderate Potassium/High Sodium Diet and High Potassium/High Sodium Diet in people with 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Mar 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?
Contact Shannon L Lennon, PhD ((302)831-2798, slennon@udel.edu), or a site near the patient. 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 the diet). The study lists 2 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 4 Mar 2026.