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Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04233957
Enrollment
50
Registered
2020-01-18
Start date
2020-01-01
Completion date
2024-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sodium Excess

Keywords

endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load

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.

Interventions

DIETARY_SUPPLEMENTHigh Sodium

10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.

OTHERPlacebo

10 days of enteric capsules filled with dextrose.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Reflected Pulse Wave AmplitudeOn 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.
Conduit artery endothelium-dependent dilationOn 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.
Arterial StiffnessOn 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

MeasureTime frameDescription
Wave reflection timingOn 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 wave transit time.
Forward Pulse Wave AmplitudeOn 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 the amplitude of the forward traveling pulse wave.
24 Hour Blood PressureThe morning of day 9 through the morning of day 10 for each arm.24 hour blood pressure monitoring will be performed using an ambulatory blood pressure monitor device. Average day and nighttime systolic, diastolic, and mean blood pressures will be determined.

Countries

United States

Contacts

Primary ContactDavid G Edwards, PhD
dge@udel.edu302-831-3363
Backup ContactJordan C Patik, PhD
jpatik@udel.edu512-820-6387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026