The Potassium Supplementation Study

NCT ID: NCT05887622

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2026-01-31

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.

Conditions

Cardiovascular Health; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Moderate potassium/low sodium

Subjects will consume a diet moderation in potassium and low in sodium.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Moderate potassium/high sodium

Subjects will consume a diet moderation in potassium and high in sodium.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

High potassium/high sodium

Subjects will consume a diet moderation in potassium and high in sodium.

Group Type: EXPERIMENTAL

Potassium chloride supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Potassium chloride supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Shannon Lennon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tower at STAR

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shannon L Lennon, PhD

Role: CONTACT

slennon@udel.edu

3023824291

Cesar J Jacintho Mortiz, PhD

Role: CONTACT

cmortiz@udel.edu

Facility Contacts

Shannon J Lennon

Role: primary

Cesar L Jacintho Mortiz

Role: backup

cmortiz@udel.edu

Other Identifiers

1465208

Identifier Type: -

Identifier Source: org_study_id