The Potassium Supplementation Study

• Sponsor: University of Delaware (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05887622
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 41.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Health; Cardiovascular Risk Factor	Dietary Supplement: Potassium chloride supplement; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All participants will complete all arms in a randomized, crossover design.All participants will complete all arms in a randomized, crossover design.
• Masking: Single (Participant)
• Masking Description: Participants will be blinded to the diet they are on.
• Primary Purpose: Prevention
• Official Title: The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions
• Actual Study Start Date: Jan 24, 2022
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Conduit artery endothelial dependent dilation [on day 10 of each diet]

   The difference in flow-mediated dilation (FMD) between the 3 diets

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tower at STAR	Newark	Delaware	United States	19713

Sponsors and Collaborators

• University of Delaware

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shannon Lennon, Associate Professor, University of Delaware
• ClinicalTrials.gov Identifier: NCT05887622
• Other Study ID Numbers: 1465208
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 5, 2023