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Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salt Pills
Placebo Pills
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • normotensive blood pressure (Systolic <120 AND Diastolic <80
  • free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease
  • non-obese (BMI <30 and/or Body fat < 25% for men, and < 30% for women)
  • no tobacco use
  • no medications that could affect vascular function or oxidative stress
  • not sedentary

Exclusion Criteria:

  • individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function
  • subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible
  • subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies
  • pregnant women, prisoners, and children will not be eligible for this study

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salt Pills

Placebo Pills

Arm Description

One week on low salt diet plus salt pills

One week on low salt diet plus placebo pills

Outcomes

Primary Outcome Measures

Arterial Dilation in Response to Exercise
Percent change is arterial diameter when compared to baseline

Secondary Outcome Measures

Full Information

First Posted
June 4, 2018
Last Updated
January 12, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03558022
Brief Title
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
Official Title
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.
Detailed Description
Sodium intake is a major contributor to the development of hypertension in the developed world. Interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals. While the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise. Therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. The investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads. Furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salt Pills
Arm Type
Experimental
Arm Description
One week on low salt diet plus salt pills
Arm Title
Placebo Pills
Arm Type
Placebo Comparator
Arm Description
One week on low salt diet plus placebo pills
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt Pills
Intervention Description
7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Pills
Intervention Description
7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals
Primary Outcome Measure Information:
Title
Arterial Dilation in Response to Exercise
Description
Percent change is arterial diameter when compared to baseline
Time Frame
After 7 day high salt supplementation vs After 7 day low salt supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: normotensive blood pressure (Systolic <120 AND Diastolic <80 free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease non-obese (BMI <30 and/or Body fat < 25% for men, and < 30% for women) no tobacco use no medications that could affect vascular function or oxidative stress not sedentary Exclusion Criteria: individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies pregnant women, prisoners, and children will not be eligible for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Garten, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake

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