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

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.

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.

Clinical Trials on Blood Pressure

Clinical Trials on Low Sodium Meal (138 mg sodium)

3
Subscribe