Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans

Cardiovascular Risk Factor Clinical Trial

Official title:

Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101188
• Other study ID #: 1472577
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Delaware
• Contact: Liza J Walker, BS
• Phone: (302)831-3181
• Email: lizaj[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.

Description:

Significant public health efforts have been made towards salt reduction but most have met with failure. Dietary factors such high sodium/low potassium diets contribute to the development of cardiovascular diseases (CVDs) such as atherosclerosis and high blood pressure (BP). This is important as CVD is the number one killer in the U.S. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation, is an important non-traditional risk factor for atherosclerosis. Evidence supporting potassium's beneficial role on vascular health remains unclear although it may be more effective in the presence of a high sodium diet. A purported mechanism responsible for sodium-induced vascular dysfunction is overproduction of reactive oxygen species (ROS) resulting in reduced nitric oxide (NO) production/bioavailability. Additionally, high sodium diets have been shown to stiffen the endothelium. This investigation will evaluate the vascular effects of dietary potassium during a high salt diet including its impact on sodium-induced oxidative stress and endothelial cell stiffness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy
• normal blood pressure
• normal resting ECG

Exclusion Criteria:

• hypertension
• history of heart disease
• diabetes
• kidney disease
• obese (BMI =30)
• significant weight changes in the last 6 months
• use of tobacco products
• pregnant
• on a special diet (gluten free; vegan)
• take any medications for the above conditions
• endurance trained athletes

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• Moderate Potassium/Low Sodium Diet
Consumption of 10 days of a diet moderate in potassium and low in sodium.
• Moderate Potassium/High Sodium Diet
Consumption of 10 days of a diet moderate in potassium and high in sodium.
• High Potassium/High Sodium Diet
Consumption of 10 days of a diet high in potassium and high in sodium.

Locations

Country	Name	City	State
United States	University of Delaware	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 change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD	on day 10 of the diet
Primary	Microvascular function	Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis	on day 10 of the diet
Secondary	Ambulatory BP monitoring	assessed by 24-hour ambulatory blood pressure	on day 7 and 10 of diet