The Potassium Supplementation Study

Not Applicable

Recruiting

• Conditions: Cardiovascular Health; Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Potassium chloride supplement

• Registration Number: NCT05887622
• Lead Sponsor: University of Delaware

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.

Study Timeline

• Study Start: 2022-01-24
• Study First Submitted: 2022-03-29
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moderate potassium/high sodium	Placebo	Subjects will consume a diet moderation in potassium and high in sodium.
Moderate potassium/low sodium	Placebo	Subjects will consume a diet moderation in potassium and low in sodium.
High potassium/high sodium	Potassium chloride supplement	Subjects will consume a diet moderation in potassium and high in sodium.

Primary Outcome Measures

Name	Time	Method
Conduit artery endothelial dependent dilation	on day 10 of each diet	The difference in flow-mediated dilation (FMD) between the 3 diets
Blood pressure reactivity	on day 10 of each diet	The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline
Superoxide levels	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

Trial Locations

Locations (1)

Tower at STAR; 🇺🇸 Newark, Delaware, United States