The Potassium Supplementation Study

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887622
• Other study ID #: 1465208
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: University of Delaware
• Contact: Shannon L Lennon, PhD
• Phone: 3023824291
• Email: slennon[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Health
• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Potassium chloride supplement
Subjects will receive 64 mmol of KCl on the high potassium/high sodium condition.
• Placebo
Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet

Locations

Country	Name	City	State
United States	Tower at STAR	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduit artery endothelial dependent dilation	The difference in flow-mediated dilation (FMD) between the 3 diets	on day 10 of each diet
Primary	Blood pressure reactivity	The change in both systolic and diastolic blood pressure during handgrip exercise and cold pressor test from baseline	on day 10 of each diet
Primary	Superoxide levels	The difference in superoxide levels as measured by electronic paramagnetic resonance (EPR) between the 3 diets will be assessed	on day 10 of each diet