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The Potassium Supplementation Study

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University of Delaware

Status

Enrolling

Conditions

Cardiovascular Health
Cardiovascular Risk Factor

Treatments

Dietary Supplement: Potassium chloride supplement
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05887622
1465208

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 3 patient groups

Moderate potassium/low sodium
Experimental group
Description:
Subjects will consume a diet moderation in potassium and low in sodium.
Treatment:
Dietary Supplement: Placebo
Moderate potassium/high sodium
Experimental group
Description:
Subjects will consume a diet moderation in potassium and high in sodium.
Treatment:
Dietary Supplement: Placebo
High potassium/high sodium
Experimental group
Description:
Subjects will consume a diet moderation in potassium and high in sodium.
Treatment:
Dietary Supplement: Potassium chloride supplement

Trial contacts and locations

1

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Central trial contact

Cesar J Jacintho Mortiz, PhD; Shannon L Lennon, PhD

Data sourced from clinicaltrials.gov

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