Skip to main content
OpenTrials
Completed

NCT Number: NCT03265353

Vascular Effects of Dietary Potassium

The purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants.

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have been implicated as risk factors including high sodium and low potassium diets. Indeed, it is well known that excess sodium can increase BP while potassium rich diets have BP lowering properties. 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. Data in animal models suggest that salt loading, independent of changes in BP, results in endothelial dysfunction while evidence is mounting that potassium may be beneficial to vascular health. Further, potassium may be more effective in the presence of high sodium however the role of potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has not been explored. A potential mechanism responsible for sodium induced vascular dysfunction is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO) production/ bioavailability. It has been suggested that potassium can counteract sodium's effect by reducing ROS. The central hypothesis is that potassium can protect against the deleterious effects of high sodium on the vasculature by reducing oxidative stress and preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding study to compare the effects of a high sodium diet (300 mmol) combined with either a high (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the vasculature, conduit artery and microvasculature. These experiments will be performed in salt-resistant participants to study the vascular effects alone, independent of changes in BP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • normal blood pressure

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

Treatment and study plan

Moderate Potassium/Low Sodium Diet

Other

7 days of the prescribed diet

Moderate Potassium/High Sodium Diet

Other

7 days of the prescribed diet

High Potassium/High Sodium Diet

Other

7 days of the prescribed diet

Primary outcomes

  1. Conduit artery endothelial-dependent dilation

    Time frame: on the 7th day of each diet

    The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD

Other outcomes

  1. Arterial Stiffness

    Time frame: on 7th day of each diet

    Assessed by carotid to femoral artery pulse wave velocity

  2. Wave reflection

    Time frame: on 7th day of each diet

    Assessed by augmentation index

  3. Endothelial cell expression of oxidative stress marker

    Time frame: on the 7th day of each diet

    Assessed in venous endothelial cells from participants.

  4. Ambulatory blood pressure

    Time frame: 7 days

    Assessed by 24 hr ambulatory blood pressure monitoring.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Vascular Effects of Dietary Potassium in Humans

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.