Cardiovascular Risk FactorNCT03265353
Vascular Effects of Dietary Potassium
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
The purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants. Read more about this study
- Who is it for?
- Ages 22 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
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2013to 22 Sep 2019
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- normal blood pressure
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.
About this study
Official title: Vascular Effects of Dietary Potassium in Humans
The purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants.
Read the detailed description
Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have been implicated as risk factors including high sodium and low potassium diets. Indeed, it is well known that excess sodium can increase BP while potassium rich diets have BP lowering properties. 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. Data in animal models suggest that salt loading, independent of changes in BP, results in endothelial dysfunction while evidence is mounting that potassium may be beneficial to vascular health. Further, potassium may be more effective in the presence of high sodium however the role of potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has not been explored. A potential mechanism responsible for sodium induced vascular dysfunction is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO) production/ bioavailability. It has been suggested that potassium can counteract sodium's effect by reducing ROS. The central hypothesis is that potassium can protect against the deleterious effects of high sodium on the vasculature by reducing oxidative stress and preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding study to compare the effects of a high sodium diet (300 mmol) combined with either a high (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the vasculature, conduit artery and microvasculature. These experiments will be performed in salt-resistant participants to study the vascular effects alone, independent of changes in BP.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Moderate Potassium/Low Sodium Diet, Moderate Potassium/High Sodium Diet, High Potassium/High Sodium Diet
- Keywords
- Potassium, Sodium, Vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Potassium/Low Sodium DietOther
7 days of the prescribed diet
Moderate Potassium/High Sodium DietOther
7 days of the prescribed diet
High Potassium/High Sodium DietOther
7 days of the prescribed diet
| Study group | Role | What they receive |
|---|---|---|
| Moderate Potassium/Low Sodium Diet | Other | Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet. Receives: Other: Moderate Potassium/Low Sodium Diet |
| Moderate Potassium/High Sodium Diet | Other | Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet. Receives: Other: Moderate Potassium/High Sodium Diet |
| High Potassium/High Sodium Diet | Other | Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet. 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 the 7th day 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 posted29 Aug 2017
- Study start25 Jul 2013
- Primary completion22 Sep 2019
- Study completion22 Sep 2019
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon L Lennon, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265353
- Sponsor's protocol ID
- 487998-8
- Status last verified
- Nov 2020
- First submitted
- 25 Aug 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effects of Dietary Potassium in Humans
- ClinicalTrials.gov ID
- NCT03265353
- Acronym / sponsor ID
- 487998-8
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Potassium, Sodium, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 25 Jul 2013 (actual)
- Primary completion
- 22 Sep 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 29 Aug 2017 (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 purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants.
Detailed description
Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have been implicated as risk factors including high sodium and low potassium diets. Indeed, it is well known that excess sodium can increase BP while potassium rich diets have BP lowering properties. 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. Data in animal models suggest that salt loading, independent of changes in BP, results in endothelial dysfunction while evidence is mounting that potassium may be beneficial to vascular health. Further, potassium may be more effective in the presence of high sodium however the role of potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has not been explored. A potential mechanism responsible for sodium induced vascular dysfunction is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO) production/ bioavailability. It has been suggested that potassium can counteract sodium's effect by reducing ROS. The central hypothesis is that potassium can protect against the deleterious effects of high sodium on the vasculature by reducing oxidative stress and preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding study to compare the effects of a high sodium diet (300 mmol) combined with either a high (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the vasculature, conduit artery and microvasculature. These experiments will be performed in salt-resistant participants to study the vascular effects alone, independent of changes in BP.
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 Diet | Other | Other: Moderate Potassium/Low Sodium DietVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet. |
| Moderate Potassium/High Sodium Diet | Other | Other: Moderate Potassium/High Sodium DietVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet. |
| High Potassium/High Sodium Diet | Other | Other: High Potassium/High Sodium DietVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- normal blood pressure
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 Diet7 days of the prescribed diet | Other | Moderate Potassium/Low Sodium Diet |
| Moderate Potassium/High Sodium Diet7 days of the prescribed diet | Other | Moderate Potassium/High Sodium Diet |
| High Potassium/High Sodium Diet7 days of the prescribed diet | Other | High Potassium/High Sodium Diet |
Primary outcome
Conduit artery endothelial-dependent dilation
Time frame: on the 7th day of each diet
The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
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 5 Nov 2020.
- 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. This study is not recruiting at the moment.
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 2 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: finished, as of the sponsor's last update on 5 Nov 2020. 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?
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?
Conduit artery endothelial-dependent dilation (time frame: on the 7th day of each diet). 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 Nov 2020.