- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03564262
Effects of Acute Dietary Sodium on Cerebrovascular Reactivity and Blood Pressure Reactivity
September 18, 2020 updated by: William Farquhar, University of Delaware
Americans eat more salt than is recommended by the American Heart Association.
This is important because consuming a high-salt diet is associated with an increased risk of cardiovascular events, like strokes and heart attacks.
In fact, consuming one high-salt meal temporarily reduces blood vessel function and it is not uncommon for Americans to consume high-salt meals.
Therefore, our laboratory is interested in determining if a single high-salt meal affects 1) brain blood vessel function at rest and 2) blood pressure responses during exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Excess dietary salt increases the risk of cardiovascular events like strokes and heart attacks, independent of resting blood pressure.
Recent data found that consuming one high-salt meal temporarily reduces endothelial function in the periphery.
This decrease in endothelial function can lead to an exaggerated blood pressure response during exercise and may also attenuate cerebrovascular reactivity at rest.
This is essential, because an exaggerated cardiovascular response to exercise and a decrease in brain blood vessel function at rest are risk factors for future cardiovascular events.
The long-term goal is to determine how dietary salt adversely affects BP and cerebrovascular regulation.
The objective of this proposal is to evaluate the impact of an acute dietary salt meal on BP response during exercise and cerebrovascular reactivity at rest.
The investigators have 2 specific aims: 1) Aim 1 will test the hypothesis that high dietary salt will reduce cerebrovascular reactivity, 2) Aim 2 will test the hypothesis that high dietary salt will augment blood pressure reactivity during exercise.
The findings of this project will shed light on how acute dietary salt affects the risk of cardiovascular events during a bout of exercise and long-term risk for cardiovascular disease and stroke.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- William B Farquhar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- normal blood pressure
- males, females, minorities
Exclusion Criteria:
- high blood pressure
- body mass index (BMI > 30 kg/m2)
- smokers or nicotine users
- those who are pregnant or planning to become pregnant
- allergy to the tomato soup
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cerebrovascular Reactivity
Cerebrovascular reactivity (CVR) will be assessed using transcranial Doppler ultrasound with carbon dioxide as the vasoactive stimuli. The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order. The CVR test will be performed prior to soup consumption as well as after soup consumption. |
One Low Sodium Meal
One High Sodium Meal
|
Experimental: Blood Pressure Reactivity
Blood pressure responses during dynamic exercise will be assessed.
The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order.
Blood pressure reactivity during dynamic exercise will be assessed after soup consumption.
|
One Low Sodium Meal
One High Sodium Meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Cerebrovascular Reactivity post soup consumption
Time Frame: Prior to and 60 minutes after soup consumption
|
Middle Cerebral Artery/ End-tidal Carbon Dioxide (cm/s/mmHg)
|
Prior to and 60 minutes after soup consumption
|
Blood Pressure Reactivity- Dynamic Exercise
Time Frame: 80 minutes after soup consumption
|
Change in Blood Pressure during dynamic exercise (mmHg)
|
80 minutes after soup consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William B Farquhar, PhD, University of Delaware
- Principal Investigator: Kamila U Migdal, BS, University of Delaware
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
June 8, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 1178955-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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