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Clinical Trials/NCT04233957
NCT04233957RecruitingNot Applicable

The Role of Oxidative Stress and Endothelial Dysfunction in High Sodium-Induced Changes in Pulsatile Hemodynamics

University of Delaware1 site in 1 country50 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Conduit artery endothelium-dependent dilation

Study Overview

Brief Summary

High sodium diets impair vascular function, which may influence the work of the heart. This investigation is designed to determine if this change in vascular function results in a greater workload in the heart and if people who regularly exercise are protected from these effects.

Detailed Description

Excess dietary sodium is associated with cardiac hypertrophy independent of changes in blood pressure. Importantly, increased arterial pulsatile load predicts left ventricular hypertrophy, and thus presents a potential mechanism through which high dietary sodium augments cardiovascular disease risk.

While high sodium diets impair vascular function via an increase in oxidative stress, how high sodium influences central pulsatile hemodynamics is not known. This project aims to a) determine how impaired vascular function affects pulsatile hemodynamics and thus influences the work of the heart during periods of high sodium consumption and b) examine whether regular aerobic exercise and/or fitness protects against the deleterious effects of excess sodium.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy individuals (age 21-45) who are either sedentary (1 or less days of exercise per week during past year) or habitually active (4 or more days of aerobic exercise per week for a minimum of 1 year)

Exclusion Criteria

  • •Body mass index <18 or >35
  • •Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90
  • •Blood donation within past 8 weeks,
  • •Glucose 6 phosphate dehydrogenase (G6PD) deficiency
  • •A history of cancer, diabetes, or any other chronic disease
  • •A history of any heart disease
  • •A history of hormone therapy
  • •Use of nicotine products
  • •Pregnancy
  • •Nursing mothers
  • •Participation in regular physical activity greater than 1 day/week- but less than 4 days/week

Arms & Interventions

High Sodium

Experimental

Consumption of an extra 3900 mg of dietary sodium per day.

Intervention: High Sodium (Dietary Supplement)

Placebo

Placebo Comparator

Control Condition

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Conduit artery endothelium-dependent dilation

Time Frame: On the 10th day of each arm.

Brachial artery flow mediated dilation (FMD) will be assessed by duplex ultrasound as an index of conduit artery endothelial function.

Reflected Pulse Wave Amplitude

Time Frame: On the 10th day of each arm.

Aortic pressure-flow relations will be assessed non-invasively using echocardiography and peripheral artery applanation tonometry. Wave separation analysis will be used to calculate reflected pulse wave amplitude.

Arterial Stiffness

Time Frame: On the 10th day of each arm.

Carotid-femoral pulse wave velocity (cf-PWV) will be assessed via applanation tonometry as an index of aortic stiffness. cf-PWV will be calculated as the difference in timing of of pulse waves at the carotid and femoral arteries divided by the distance between measurements.

Secondary Outcomes

  • Wave reflection timing(On the 10th day of each arm.)
  • Forward Pulse Wave Amplitude(On the 10th day of each arm.)
  • 24 Hour Blood Pressure(The morning of day 9 through the morning of day 10 for each arm.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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