Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

Sodium Excess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233957
• Other study ID #: 1452626
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Delaware
• Contact: David G Edwards, PhD
• Phone: 302-831-3363
• Email: dge[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypernatremia
• Sodium Excess

Intervention

Dietary Supplement:
• High Sodium
10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.

Other:
• Placebo
10 days of enteric capsules filled with dextrose.

Locations

Country	Name	City	State
United States	Department of Kinesiology and Applied Physiology, University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflected Pulse Wave Amplitude	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.	On the 10th day of each arm.
Primary	Conduit artery endothelium-dependent dilation	Brachial artery flow mediated dilation (FMD) will be assessed by duplex ultrasound as an index of conduit artery endothelial function.	On the 10th day of each arm.
Primary	Arterial Stiffness	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.	On the 10th day of each arm.
Secondary	Wave reflection timing	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.	On the 10th day of each arm.
Secondary	Forward Pulse Wave Amplitude	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.	On the 10th day of each arm.
Secondary	24 Hour Blood Pressure	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.	The morning of day 9 through the morning of day 10 for each arm.