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

NCT ID: NCT03558022

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2021-11-05

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Salt Pills

One week on low salt diet plus salt pills

Group Type EXPERIMENTAL

Salt Pills

Intervention Type DIETARY_SUPPLEMENT

7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)

Placebo Pills

One week on low salt diet plus placebo pills

Group Type PLACEBO_COMPARATOR

Placebo Pills

Intervention Type DIETARY_SUPPLEMENT

7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals

Interventions

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Salt Pills

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

Placebo Pills

7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Garten, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20013060

Identifier Type: -

Identifier Source: org_study_id

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