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Active, Not Recruiting

NCT Number: NCT05887622

The Potassium Supplementation Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tower at STAR

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potassium chloride supplement

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Conduit artery endothelial dependent dilation

    Time frame: on day 10 of each diet

    The difference in flow-mediated dilation (FMD) between the 3 diets

  2. Blood pressure reactivity

    Time frame: on day 10 of each diet

    The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline

  3. Superoxide levels

    Time frame: on day 10 of each diet

    The difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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