NCT03265353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2019

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

6.2 years

First QC Date

August 25, 2017

Last Update Submit

November 4, 2020

Conditions

Keywords

PotassiumSodiumVascular function

Outcome Measures

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

    on the 7th day of each diet

Other Outcomes (4)

  • Arterial Stiffness

    on 7th day of each diet

  • Wave reflection

    on 7th day of each diet

  • Endothelial cell expression of oxidative stress marker

    on the 7th day of each diet

  • +1 more other outcomes

Study Arms (3)

Moderate Potassium/Low Sodium Diet

OTHER

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

Moderate Potassium/High Sodium Diet

OTHER

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

High Potassium/High Sodium Diet

OTHER

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

7 days of the prescribed diet

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

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • normal blood pressure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Study Officials

  • Shannon L Lennon, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: All participants will complete each arm. It is a crossover, randomized design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

July 25, 2013

Primary Completion

September 22, 2019

Study Completion

September 22, 2019

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations