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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05887622
Other study ID # 1465208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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