Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics
NCT ID: NCT04233957
Last Updated: 2023-11-29
Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-01-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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High Sodium
Consumption of an extra 3900 mg of dietary sodium per day.
High Sodium
10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.
Placebo
Control Condition
Placebo
10 days of enteric capsules filled with dextrose.
Interventions
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High Sodium
10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.
Placebo
10 days of enteric capsules filled with dextrose.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
45 Years
ALL
Yes
Sponsors
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University of Delaware
OTHER
Responsible Party
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Principal Investigators
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David G Edwards, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Delaware
Locations
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Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1452626
Identifier Type: -
Identifier Source: org_study_id