Healthy Older AdultsNCT07649005
Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults
A study testing low sodium/low potassium diet, high sodium/low potassium diet and high sodium/high potassium diet in people with Healthy Older Adults, run by Florida State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults
- What is being tested?
- low sodium/low potassium diet, high sodium/low potassium diet and high sodium/high potassium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 30 Jun 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ages 55-75 years
- At least one-year post-menopause (females)
- Willing and able to attend laboratory visits
Who cannot join
- BMI ≥35 kg/m2
- Seated blood pressure >135/85 mmHg
- Current diagnosis or history of cardiovascular disease, diabetes, renal disease, cancer, or major cardiovascular event (e.g. heart attack or stroke)
- Taking exogenous hormones or hormone replacement therapy
- Following a vegan or gluten free diet
- Significant weight loss (>10% of body weight) in the last 6 months, or actively trying to lose weight
Show all 17Show fewer
- Current or recent use of a diuretic (within the past 6 months) (e.g. spironolactone, eplerenone)
- Current or recent use of a potassium binding medication (within the past 6 months)
- Current use of blood pressure lowering medications (e.g. ACE inhibitors, calcium channel blockers, diuretics, vasodilators, beta blockers, AngII receptor blockers)
- Current or recent use of the medication trimethoprim
- Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
- Elevated serum potassium level (>5.1 mmol/L)
- 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)
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, 32306
Andrea Lobene, 850-644-1829, alobene@fsu.edu
About this study
Official title: Exploring the Interactive Effects of Sodium and Potassium Intake on Vascular Health in Older Adults
The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are:
- Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults.
- Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.
Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.
Read the detailed description
Cardiovascular health declines with age, especially in postmenopausal females. 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 young adults, even if sodium intake remains high. The investigators are hoping to show that potassium can improve cardiovascular health in the context of a high sodium diets in older adults. In this study, participants will consume three 10-day controlled diets in a randomized order. The study diets will include: 1) a low sodium (2,000 mg/day)/low potassium (2,000 mg/day) diet; 2) a high sodium (4,700 mg/day)/usual potassium diet; and 3) a high sodium/high potassium (4,700 mg/day). All food will be provided to participants during these periods, and participants will be instructed not to consume any outside food or beverages. Dietary interventions will be separated by a minimum two-week washout period. Measurements of cardiovascular health will be collected at the end of each diet.
- Conditions
- Healthy Older Adults
- Being tested
- low sodium/low potassium diet, high sodium/low potassium diet, high sodium/high potassium diet
- Keywords
- sodium, potassium, 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.
low sodium/low potassium dietOther
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
high sodium/low potassium dietOther
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
high sodium/high potassium dietOther
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
| Study group | Role | What they receive |
|---|---|---|
| low Na/low K, high Na/low K, high Na/high K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
| low Na/low K, high Na/high K, high Na/low K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
| high Na/high K, low Na/low K, high Na/low K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
| high Na/high K, high Na/low K, low Na/low K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
| high Na/low K, low Na/low K, high Na/high K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
| high Na/low K, high Na/high K, low Na/low K | Experimental | Three 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. Receives: Other: low sodium/low potassium diet; Other: high sodium/low potassium diet; Other: high sodium/high potassium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Brachial artery flow-mediated dilation as measured in % dilation
Measured: "Day 11" after each of the three 10-day dietary interventions
Blood pressure
24-hour ambulatory blood pressure
Measured: "Day 11" after each of the three 10-day dietary interventions
Arterial stiffness
Carotid-femoral pulse wave velocity
Measured: "Day 11" after each of the three 10-day dietary interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start24 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Older AdultsStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Principal investigator, Andrea Lobene, Florida State University
- Investigators
- Andrea Lobene, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649005
- Sponsor's protocol ID
- STUDY00006676
- Other IDs
- UF-FSU CTSA Career Development
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Interactive Effects of Sodium and Potassium Intake on Vascular Health in Older Adults
- ClinicalTrials.gov ID
- NCT07649005
- Acronym / sponsor ID
- STUDY00006676
- Conditions
- Healthy Older Adults
- Keywords
- sodium, potassium, endothelial function, cardiovascular disease risk factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jun 2026 (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 high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are:
- Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults.
- Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.
Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.
Detailed description
Cardiovascular health declines with age, especially in postmenopausal females. 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 young adults, even if sodium intake remains high. The investigators are hoping to show that potassium can improve cardiovascular health in the context of a high sodium diets in older adults. In this study, participants will consume three 10-day controlled diets in a randomized order. The study diets will include: 1) a low sodium (2,000 mg/day)/low potassium (2,000 mg/day) diet; 2) a high sodium (4,700 mg/day)/usual potassium diet; and 3) a high sodium/high potassium (4,700 mg/day). All food will be provided to participants during these periods, and participants will be instructed not to consume any outside food or beverages. Dietary interventions will be separated by a minimum two-week washout period. Measurements of cardiovascular health will be collected at the end of each diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| low Na/low K, high Na/low K, high Na/high K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
| low Na/low K, high Na/high K, high Na/low K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
| high Na/high K, low Na/low K, high Na/low K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
| high Na/high K, high Na/low K, low Na/low K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
| high Na/low K, low Na/low K, high Na/high K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
| high Na/low K, high Na/high K, low Na/low K | Experimental | Other: low sodium/low potassium diet, Other: high sodium/low potassium diet, Other: high sodium/high potassium dietThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ages 55-75 years
- At least one-year post-menopause (females)
- Willing and able to attend laboratory visits
Key exclusion criteria (17 listed)
- BMI ≥35 kg/m2
- Seated blood pressure >135/85 mmHg
- Current diagnosis or history of cardiovascular disease, diabetes, renal disease, cancer, or major cardiovascular event (e.g. heart attack or stroke)
- Taking exogenous hormones or hormone replacement therapy
- Following a vegan or gluten free diet
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 |
|---|---|---|
| low sodium/low potassium dietOn this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day | Other | high Na/high K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/low K, high Na/low K, high Na/high K, low Na/low K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/high K, high Na/low K, low Na/low K, high Na/low K, high Na/high K |
| high sodium/low potassium dietOn this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day | Other | high Na/high K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/low K, high Na/low K, high Na/high K, low Na/low K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/high K, high Na/low K, low Na/low K, high Na/low K, high Na/high K |
| high sodium/high potassium dietOn this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day | Other | high Na/high K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/low K, high Na/low K, high Na/high K, low Na/low K, high Na/low K, low Na/low K, high Na/high K, low Na/low K, high Na/high K, high Na/low K, low Na/low K, high Na/low K, high Na/high K |
Primary outcome
Endothelial function
Time frame: "Day 11" after each of the three 10-day dietary interventions
Brachial artery flow-mediated dilation as measured in % dilation
Blood pressure
Time frame: "Day 11" after each of the three 10-day dietary interventions
24-hour ambulatory blood pressure
Arterial stiffness
Time frame: "Day 11" after each of the three 10-day dietary interventions
Carotid-femoral pulse wave velocity
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 15 Jun 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 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 low sodium/low potassium diet, high sodium/low potassium diet and high sodium/high potassium diet in people with Healthy Older Adults, 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 17 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 15 Jun 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 (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?
Endothelial function (time frame: "Day 11" after each of the three 10-day dietary interventions). 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 15 Jun 2026.