Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans
2 other identifiers
interventional
90
1 country
1
Brief Summary
Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
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
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
January 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
March 4, 2026
March 1, 2026
6.5 years
September 23, 2019
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Conduit artery endothelial-dependent dilation
The change in flow-mediated dilation (FMD) between the 3 diets as assessed by brachial artery FMD
on day 10 of the diet
Microvascular function
Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
on day 10 of the diet
Secondary Outcomes (1)
Ambulatory BP monitoring
on day 7 and 10 of diet
Study Arms (3)
Moderate Potassium/Low Sodium
EXPERIMENTALSubjects will be provided with a diet that is moderate in potassium and low in sodium.
Moderate Potassium/High Sodium
EXPERIMENTALSubjects will be provided with a diet that is moderate in potassium and high in sodium.
High Potassium/High Sodium
EXPERIMENTALSubjects will be provided with a diet that is high in both potassium and sodium.
Interventions
Consumption of 10 days of a diet moderate in potassium and low in sodium.
Consumption of 10 days of a diet moderate in potassium and high in sodium.
Consumption of 10 days of a diet high in potassium and high in sodium.
Eligibility Criteria
You may qualify if:
- healthy
- normal blood pressure
- normal resting ECG
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
Central Study Contacts
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
September 23, 2019
First Posted
September 24, 2019
Study Start
January 16, 2020
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03