Interactive Effects of Sodium and Potassium on Vascular Health in Older Adults
Exploring the Interactive Effects of Sodium and Potassium Intake on Vascular Health in Older Adults
2 other identifiers
interventional
30
1 country
1
Brief 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.Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults.
- 2.Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2026
CompletedFirst Submitted
Initial submission to the registry
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 15, 2026
June 1, 2026
1.3 years
June 9, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Endothelial function
Brachial artery flow-mediated dilation as measured in % dilation
"Day 11" after each of the three 10-day dietary interventions
Blood pressure
24-hour ambulatory blood pressure
"Day 11" after each of the three 10-day dietary interventions
Arterial stiffness
Carotid-femoral pulse wave velocity
"Day 11" after each of the three 10-day dietary interventions
Study Arms (6)
low Na/low K, high Na/low K, high Na/high K
EXPERIMENTALThree 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
EXPERIMENTALThree 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
EXPERIMENTALThree 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
EXPERIMENTALThree 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
EXPERIMENTALThree 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
EXPERIMENTALThree 10-day controlled diets in randomized order, each varying in sodium and potassium content. There is a minimum 2-week washout between diets.
Interventions
On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day
On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day
Eligibility Criteria
You may qualify if:
- Adults ages 55-75 years
- At least one-year post-menopause (females)
- Willing and able to attend laboratory visits
You may not qualify if:
- 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
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida State Universitylead
- University of Floridacollaborator
Study Sites (1)
Florida State University
Tallahassee, Florida, 32306, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Lobene
Florida State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 9, 2026
First Posted
June 15, 2026
Study Start
March 24, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share