Vascular Effects of Dietary Potassium
1 other identifier
interventional
47
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2013
CompletedFirst Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2019
CompletedNovember 5, 2020
November 1, 2020
6.2 years
August 25, 2017
November 4, 2020
Conditions
Keywords
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
OTHERVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/low sodium diet.
Moderate Potassium/High Sodium Diet
OTHERVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the moderate potassium/high sodium diet.
High Potassium/High Sodium Diet
OTHERVascular function will be assessed at both the conduit artery and microvascular level after 7 days of the high potassium/high sodium diet.
Interventions
7 days of the prescribed diet
7 days of the prescribed diet
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon L Lennon, PhD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- 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