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The Potassium Supplementation Study

The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05887622
Enrollment
30
Registered
2023-06-05
Start date
2022-01-24
Completion date
2026-12-31
Last updated
2026-05-05

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

Conditions

Cardiovascular Health, Cardiovascular Risk Factor

Brief summary

This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.

Detailed description

Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.

Interventions

DIETARY_SUPPLEMENTPotassium chloride supplement

Subjects will receive 64 mmol of KCl on the high potassium/high sodium condition.

DIETARY_SUPPLEMENTPlacebo

Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will be blinded to the diet they are on.

Intervention model description

All participants will complete all arms in a randomized, crossover design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* men and women * 18-45 years of age * all races/ethnicities * BMI \< 30 kg/m2 * BP \< 130/80 mmHg

Exclusion criteria

* presence of hypertension * known heart disease * diabetes * kidney disease * cancer * inflammatory conditions * blood clotting disorders * pregnancy * adrenal gland disorder * history of stomach or intestinal bleeding * history of kidney stones * serum potassium outside of the normal range

Design outcomes

Primary

MeasureTime frameDescription
Conduit artery endothelial dependent dilationon day 10 of each dietThe difference in flow-mediated dilation (FMD) between the 3 diets
Blood pressure reactivityon day 10 of each dietThe change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline
Superoxide levelson day 10 of each dietThe difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026