Clinical trial NCT04101188: Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans
Official title: Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Dietary Potassium
Dietary Sodium
Vascular Health
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete each arm. It is a crossover, randomized design.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Conduit artery endothelial-dependent dilation
timeFrame: on day 10 of the diet
measure: Microvascular function
timeFrame: on day 10 of the diet
Secondary outcomes:
measure: Ambulatory BP monitoring
timeFrame: on day 7 and 10 of diet
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Shannon L Lennon, PhD
role: PRINCIPAL_INVESTIGATOR
References: