Vascular Effects of Dietary Potassium

Cardiovascular Risk Factor Clinical Trial

Official title:

Vascular Effects of Dietary Potassium in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265353
• Other study ID #: 487998-8
• Status: Completed
• Phase: N/A
• Start date: July 25, 2013
• Est. completion date: September 22, 2019

Study information

• Verified date: November 2020
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 22, 2019
• Est. primary completion date: September 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• Moderate Potassium/Low Sodium Diet
7 days of the prescribed diet
• Moderate Potassium/High Sodium Diet
7 days of the prescribed diet
• High Potassium/High Sodium Diet
7 days of the prescribed diet

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
Other	Arterial Stiffness	Assessed by carotid to femoral artery pulse wave velocity	on 7th day of each diet
Other	Wave reflection	Assessed by augmentation index	on 7th day of each diet
Other	Endothelial cell expression of oxidative stress marker	Assessed in venous endothelial cells from participants.	on the 7th day of each diet
Other	Ambulatory blood pressure	Assessed by 24 hr ambulatory blood pressure monitoring.	7 days
Primary	Conduit artery endothelial-dependent dilation	The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD	on the 7th day of each diet