Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

University of Delaware

Status: Enrolling

Conditions: Sodium Excess

Treatments: Dietary Supplement: High Sodium; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04233957

1452626

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

High Sodium

Experimental group

Description:

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

Treatment:

Dietary Supplement: High Sodium

Placebo

Placebo Comparator group

Description:

Control Condition

Treatment:

Other: Placebo