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Vascular Effects of Dietary Potassium

NCT ID: NCT03265353

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-25

Study Completion Date

2019-09-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will complete each arm. It is a crossover, randomized design.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate Potassium/Low Sodium Diet

Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet.

Group Type OTHER

Moderate Potassium/Low Sodium Diet

Intervention Type OTHER

7 days of the prescribed diet

Moderate Potassium/High Sodium Diet

Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet.

Group Type OTHER

Moderate Potassium/High Sodium Diet

Intervention Type OTHER

7 days of the prescribed diet

High Potassium/High Sodium Diet

Vascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet.

Group Type OTHER

High Potassium/High Sodium Diet

Intervention Type OTHER

7 days of the prescribed diet

Interventions

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Moderate Potassium/Low Sodium Diet

7 days of the prescribed diet

Intervention Type OTHER

Moderate Potassium/High Sodium Diet

7 days of the prescribed diet

Intervention Type OTHER

High Potassium/High Sodium Diet

7 days of the prescribed diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon L Lennon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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University of Delaware

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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487998-8

Identifier Type: -

Identifier Source: org_study_id