The Potassium Supplementation Study

NCT05887622 | Active Not Recruiting

• 1 other identifier: 1465208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Health; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Moderate potassium/low sodium

EXPERIMENTAL

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

Dietary Supplement: Placebo

Moderate potassium/high sodium

EXPERIMENTAL

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

Dietary Supplement: Placebo

High potassium/high sodium

EXPERIMENTAL

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

Dietary Supplement: Potassium chloride supplement

Interventions

Potassium chloride supplement DIETARY_SUPPLEMENT

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

High potassium/high sodium

Placebo 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; Moderate potassium/low sodium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• men and women
• years of age
• all races/ethnicities
• BMI \< 30 kg/m2
• BP \< 130/80 mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

Tower at STAR

Newark, Delaware, 19713, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the diet they are on.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will complete all arms in a randomized, crossover design.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: June 5, 2023
• Study Start: January 24, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)