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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07649005
Enrollment
30
Registered
2026-06-15
Start date
2026-03-24
Completion date
2027-06-30
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Older Adults

Keywords

sodium, potassium, endothelial function, cardiovascular disease risk factors

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. 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.

Interventions

OTHERlow sodium/low potassium diet

On this intervention, participants will be given a diet that provides 2,000 mg Na/day and 2,000 mg K/day

OTHERhigh sodium/low potassium diet

On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 2,000 mg K/day

OTHERhigh sodium/high potassium diet

On this intervention, participants will be given a diet that provides 4,700 mg Na/day and 4,700 mg K/day

Sponsors

Florida State University
Lead SponsorOTHER
University of Florida
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults ages 55-75 years * At least one-year post-menopause (females) * Willing and able to attend laboratory visits

Exclusion criteria

* 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) * Current or recent use of tobacco, nicotine, or illicit drugs * Radical hysterectomy or oophorectomy (females)

Design outcomes

Primary

MeasureTime frameDescription
Endothelial function"Day 11" after each of the three 10-day dietary interventionsBrachial artery flow-mediated dilation as measured in % dilation
Blood pressure"Day 11" after each of the three 10-day dietary interventions24-hour ambulatory blood pressure
Arterial stiffness"Day 11" after each of the three 10-day dietary interventionsCarotid-femoral pulse wave velocity

Countries

United States

Contacts

CONTACTAndrea Lobene
alobene@fsu.edu850-644-1829
CONTACTFSU Ann's College
850-644-6685
PRINCIPAL_INVESTIGATORAndrea Lobene

Florida State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026