The Potassium Supplementation Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk Factor; Cardiovascular Health
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Potassium chloride supplement

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon L Lennon, PhD; Phone Number: 3023824291; Email: slennon@udel.edu
• Study Contact Backup: Name: Andrea J Lobene, PhD; Email: alobene@udel.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Tower at STAR
      • Contact: Andrea J Lobene; Email: alobene@udel.edu
      • Contact: Shannon L Lennon; Email: slennon@udel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate potassium/low sodium; Subjects will consume a diet moderation in potassium and low in sodium.	Dietary supplement: Placebo; Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet
Experimental: Moderate potassium/high sodium; Subjects will consume a diet moderation in potassium and high in sodium.	Dietary supplement: Placebo; Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet
Experimental: High potassium/high sodium; Subjects will consume a diet moderation in potassium and high in sodium.	Dietary supplement: Potassium chloride supplement; Subjects will receive 64 mmol of KCl on the high potassium/high sodium condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conduit artery endothelial dependent dilation	The difference in flow-mediated dilation (FMD) between the 3 diets	on day 10 of each diet
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
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

Collaborators and Investigators

• Sponsor: University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1465208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No