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CompletedNCT03265353Updated Nov 5, 2020

Vascular Effects of Dietary Potassium

An interventional study of Moderate Potassium/Low Sodium Diet and Moderate Potassium/High Sodium Diet in Cardiovascular Risk Factor, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 22 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by University of Delaware · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
22 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cardiovascular Risk Factor

Keywords

  • Potassium
  • Sodium
  • Vascular function
03

Who can participate

Ages eligible
22 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy
  • normal blood pressure

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Other
    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.

    Other: Moderate Potassium/Low Sodium Diet

  • Other
    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.

    Other: Moderate Potassium/High Sodium Diet

  • Other
    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.

    Other: High Potassium/High Sodium Diet

Interventions

  • OtherModerate Potassium/Low Sodium Diet

    7 days of the prescribed diet

  • OtherModerate Potassium/High Sodium Diet

    7 days of the prescribed diet

  • OtherHigh Potassium/High Sodium Diet

    7 days of the prescribed diet

05

What researchers measure

Primary outcomes

  1. Conduit artery endothelial-dependent dilation

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

    Time frame: on the 7th day of each diet

Other outcomes

  1. Arterial Stiffness

    Assessed by carotid to femoral artery pulse wave velocity

    Time frame: on 7th day of each diet

  2. Wave reflection

    Assessed by augmentation index

    Time frame: on 7th day of each diet

  3. Endothelial cell expression of oxidative stress marker

    Assessed in venous endothelial cells from participants.

    Time frame: on the 7th day of each diet

  4. Ambulatory blood pressure

    Assessed by 24 hr ambulatory blood pressure monitoring.

    Time frame: 7 days

06

Study locations

1 site
  • University of Delaware
    Newark, Delaware 19716, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03265353
Lead sponsor
University of Delaware
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Jul 25, 2013
Primary completion
Sep 22, 2019
Completion
Sep 22, 2019
Last update
Nov 5, 2020

Study contacts

Shannon L Lennon, PhD
principal investigator · University of Delaware

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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