HealthyNCT07221448
Sodium vs Potassium Education to Improve Vascular Health
A study testing High potassium dietary education/counseling and Low sodium dietary education/counseling in people with Healthy, run by Florida State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving vascular health than a low sodium diet in generally healthy young adults who typically consume more than the recommended amount of sodium. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High potassium dietary education/counseling and Low sodium dietary education/counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 30 Sep 2027
- 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
- Willing and able to attend in-person laboratory visits
- Usual sodium intake ≥3,000 mg/d for females and ≥4,000 mg/d for males
- Usual potassium intake ≤2,500 mg/d in females and ≤3,000 mg/d in males
Who cannot join
- BMI ≥35 kg/m2
- Seated blood pressure ≥130/80 mmHg
- Current diagnosis or history of diabetes, renal disease, cancer, cardiovascular disease, or major cardiovascular event (e.g. heart attack or stroke)
- Current or recent use of a diuretic (within the past 6 months)
- Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
- Elevated serum potassium level (>5.1 mmol/L)
Show all 13Show fewer
- Elevated BUN (>22 mg/dL)
- Elevated creatinine (>1.2 mg/dL)
- Low eGFR (<90 mL/min/1.73 m²)
- Current or recent use of tobacco, nicotine, or illicit drugs
- Radical hysterectomy or oophorectomy (females)*
- Pregnant or lactating
- Following a weight-loss diet, or intending to gain or lose weight during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
FSU Ann's College contact
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32304
Andrea Lobene, PhD, RD, LD, 850-644-1829, alobene@fsu.edu
About this study
Official title: Improving Vascular Health Using Nutrition Education Aimed At Increasing Potassium Intake Versus Reducing Sodium Intake
The goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving vascular health than a low sodium diet in generally healthy young adults who typically consume more than the recommended amount of sodium. The main questions it aims to answer are:
- Is it easier for young adults to increase their potassium intake, rather than reduce their sodium intake?
- Is a self-selected high potassium diet better at improving vascular health compared to a self-selected low sodium diet?
Read more
Researchers will compare the effectiveness of an education-based intervention centered only on increasing dietary potassium intake against an education-based intervention centered only on reducing dietary sodium intake.
Participants will be randomly assigned to receive comprehensive dietary education on adopting either a high-potassium diet or a low-sodium diet.
Education will be delivered in four weekly one-on-one sessions. Following the four-week education period, participants will be encouraged to change their diet based on what they have learned. Measures of dietary compliance (urine samples and diet records) and cardiovascular health (blood pressure, endothelial function) will be assessed at two, four, and six months post-education.
Read the detailed description
High sodium diets are a major contributor to cardiovascular disease. Unfortunately, reducing sodium intake can be challenging. It is known that increasing potassium intake can improve cardiovascular disease risk factors in a laboratory setting. The investigators are hoping to show that it is more feasible and effective for individuals to increase their potassium intake, rather than reduce their sodium intake, to improve cardiovascular disease risk factors, including blood pressure and endothelial function.
In this study, participants will be randomly assigned to receive individualized education over the course of four weeks to help them adopt one of two dietary patterns: 1) a self-selected low sodium diet (goal: ≤1,500 mg/day) or 2) a self-selected high potassium diet (goal: ≥4,700 mg/day). Participants will be provided individualized nutrition education once per week, at the participant's convenience by trained study staff to help them meet the target nutrition goals. No food, supplements, or devices will be provided to participants, and participants will be advised not to take any dietary supplements containing potassium during the intervention and follow-up period. Follow up with participants will be every two months for six months post-education to measure compliance with the desired dietary changes as well as changes in cardiovascular health.
- Conditions
- Healthy
- Being tested
- High potassium dietary education/counseling, Low sodium dietary education/counseling
- Keywords
- sodium, potassium, nutrition education, endothelial function, cardiovascular disease risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High potassium dietary education/counselingBehavioural
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to increase their dietary potassium intake.
Low sodium dietary education/counselingBehavioural
Participants assigned to this intervention arm will receive four weekly individualized education sessions on how to reduce their dietary sodium intake.
| Study group | Role | What they receive |
|---|---|---|
| High potassium dietary education | Experimental | Not described Receives: Behavioral: High potassium dietary education/counseling |
| Low sodium dietary education | Active comparator | Not described Receives: Behavioral: Low sodium dietary education/counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary sodium intake
Dietary sodium intake will be assessed via participant self-reported 3 day diet record
Measured: Baseline; 2 month, 4month, 6month
Change in dietary potassium intake
Dietary potassium intake will be assessed via participant self-reported 3-day diet record
Measured: Baseline, 2month, 4month, 6month
Change in 24-hour urinary sodium excretion
Urinary sodium excretion obtained from 24-hour urine sample
Measured: Baseline, 2month, 4month, 6month
Change in 24-hour urinary potassium excretion
Urinary potassium excretion measured from 24-hour urine sample
Measured: Baseline, 2month, 4month, 6month
Change in Blood pressure
Seated, automated blood pressure mmHg
Measured: Baseline; 2 month, 4month, 6month
Change in Endothelial function
brachial artery flow-mediated dilation as measured in % dilation
Measured: Baseline; 2 month, 4month, 6month
Secondary outcomes (2)
Direct measurement of arterial stiffness
Carotid-femoral pulse wave velocity reported in m/s
Measured: Baseline, 2month, 4month, 6month
Indirect measurement of arterial stiffness
Augmentation obtained from the brachial artery pressure waveform using a blood pressure cuff on the upper arm, reported as %
Measured: Baseline, 2month, 4month, 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start20 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Andrea Lobene, Florida State University
- Investigators
- Andrea Lobene, PhD, RD, LD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221448
- Sponsor's protocol ID
- STUDY00005997
- Other IDs
- 2025-67017-44996, 2025
- Status last verified
- Feb 2026
- First submitted
- 24 Oct 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vascular Health Using Nutrition Education Aimed At Increasing Potassium Intake Versus Reducing Sodium Intake
- ClinicalTrials.gov ID
- NCT07221448
- Acronym / sponsor ID
- STUDY00005997
- Conditions
- Healthy
- Keywords
- sodium, potassium, nutrition education, endothelial function, cardiovascular disease risk factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Oct 2025 (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 goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving vascular health than a low sodium diet in generally healthy young adults who typically consume more than the recommended amount of sodium. The main questions it aims to answer are:
- Is it easier for young adults to increase their potassium intake, rather than reduce their sodium intake?
- Is a self-selected high potassium diet better at improving vascular health compared to a self-selected low sodium diet?
Researchers will compare the effectiveness of an education-based intervention centered only on increasing dietary potassium intake against an education-based intervention centered only on reducing dietary sodium intake.
Participants will be randomly assigned to receive comprehensive dietary education on adopting either a high-potassium diet or a low-sodium diet.
Education will be delivered in four weekly one-on-one sessions. Following the four-week education period, participants will be encouraged to change their diet based on what they have learned. Measures of dietary compliance (urine samples and diet records) and cardiovascular health (blood pressure, endothelial function) will be assessed at two, four, and six months post-education.
Detailed description
High sodium diets are a major contributor to cardiovascular disease. Unfortunately, reducing sodium intake can be challenging. It is known that increasing potassium intake can improve cardiovascular disease risk factors in a laboratory setting. The investigators are hoping to show that it is more feasible and effective for individuals to increase their potassium intake, rather than reduce their sodium intake, to improve cardiovascular disease risk factors, including blood pressure and endothelial function.
In this study, participants will be randomly assigned to receive individualized education over the course of four weeks to help them adopt one of two dietary patterns: 1) a self-selected low sodium diet (goal: ≤1,500 mg/day) or 2) a self-selected high potassium diet (goal: ≥4,700 mg/day). Participants will be provided individualized nutrition education once per week, at the participant's convenience by trained study staff to help them meet the target nutrition goals. No food, supplements, or devices will be provided to participants, and participants will be advised not to take any dietary supplements containing potassium during the intervention and follow-up period. Follow up with participants will be every two months for six months post-education to measure compliance with the desired dietary changes as well as changes in cardiovascular health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High potassium dietary education | Experimental | Behavioral: High potassium dietary education/counseling |
| Low sodium dietary education | Active comparator | Behavioral: Low sodium dietary education/counseling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing and able to attend in-person laboratory visits
- Usual sodium intake ≥3,000 mg/d for females and ≥4,000 mg/d for males
- Usual potassium intake ≤2,500 mg/d in females and ≤3,000 mg/d in males
Key exclusion criteria (13 listed)
- BMI ≥35 kg/m2
- Seated blood pressure ≥130/80 mmHg
- Current diagnosis or history of diabetes, renal disease, cancer, cardiovascular disease, or major cardiovascular event (e.g. heart attack or stroke)
- Current or recent use of a diuretic (within the past 6 months)
- Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
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 |
|---|---|---|
| High potassium dietary education/counselingParticipants assigned to this intervention arm will receive four weekly individualized education sessions on how to increase their dietary potassium intake. | Behavioural | High potassium dietary education |
| Low sodium dietary education/counselingParticipants assigned to this intervention arm will receive four weekly individualized education sessions on how to reduce their dietary sodium intake. | Behavioural | Low sodium dietary education |
Primary outcome
Change in dietary sodium intake
Time frame: Baseline; 2 month, 4month, 6month
Dietary sodium intake will be assessed via participant self-reported 3 day diet record
Change in dietary potassium intake
Time frame: Baseline, 2month, 4month, 6month
Dietary potassium intake will be assessed via participant self-reported 3-day diet record
Change in 24-hour urinary sodium excretion
Time frame: Baseline, 2month, 4month, 6month
Urinary sodium excretion obtained from 24-hour urine sample
Change in 24-hour urinary potassium excretion
Time frame: Baseline, 2month, 4month, 6month
Urinary potassium excretion measured from 24-hour urine sample
Change in Blood pressure
Time frame: Baseline; 2 month, 4month, 6month
Seated, automated blood pressure mmHg
Change in Endothelial function
Time frame: Baseline; 2 month, 4month, 6month
brachial artery flow-mediated dilation as measured in % dilation
2 secondary outcomes
Direct measurement of arterial stiffness
Time frame: Baseline, 2month, 4month, 6month
Indirect measurement of arterial stiffness
Time frame: Baseline, 2month, 4month, 6month
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
FSU Ann's College contact
Andrea Lobene, PhD, RD, LD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High potassium dietary education/counseling and Low sodium dietary education/counseling in people with Healthy, run by Florida State University 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 13 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 23 Apr 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 Andrea Lobene, PhD, RD, LD (850-644-1829, alobene@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary sodium intake (time frame: Baseline; 2 month, 4month, 6month). The study lists 6 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 23 Apr 2026.