Sodium ExcessNCT04233957
Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics
A study testing High Sodium in people with Sodium Excess, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium Excess
- What is being tested?
- High Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
David Edwards, PhD, dge@udel.edu
Jordan Patik, PhD, jpatik@udel.edu
About this study
Official title: The Role of Oxidative Stress and Endothelial Dysfunction in High Sodium-Induced Changes in Pulsatile Hemodynamics
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.
Read the 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.
- Conditions
- Sodium Excess
- Being tested
- High Sodium, Placebo
- Keywords
- endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load
- Medical subject headings
- Hypernatremia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High SodiumDietary supplement
10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.
PlaceboOther
10 days of enteric capsules filled with dextrose.
| Study group | Role | What they receive |
|---|---|---|
| High Sodium | Experimental | Consumption of an extra 3900 mg of dietary sodium per day. Receives: Dietary Supplement: High Sodium |
| Placebo | Placebo comparator | Control Condition Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the 10th day of each arm.
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.
Measured: On the 10th day of each arm.
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.
Measured: On the 10th day of each arm.
Secondary outcomes (3)
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.
Measured: On the 10th day of each arm.
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.
Measured: On the 10th day of each arm.
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.
Measured: The morning of day 9 through the morning of day 10 for each arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G Edwards, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233957
- Sponsor's protocol ID
- 1452626
- Status last verified
- Nov 2023
- First submitted
- 23 Dec 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxidative Stress and Endothelial Dysfunction in High Sodium-Induced Changes in Pulsatile Hemodynamics
- ClinicalTrials.gov ID
- NCT04233957
- Acronym / sponsor ID
- 1452626
- Conditions
- Sodium Excess
- Keywords
- endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sodium | Experimental | Dietary Supplement: High SodiumConsumption of an extra 3900 mg of dietary sodium per day. |
| Placebo | Placebo comparator | Other: PlaceboControl Condition |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Sodium10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt. | Dietary supplement | High Sodium |
| Placebo10 days of enteric capsules filled with dextrose. | Other | Placebo |
Primary outcome
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.
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.
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.
3 secondary outcomes
Wave reflection timing
Time frame: On the 10th day of each arm.
Forward Pulse Wave Amplitude
Time frame: On the 10th day of each arm.
24 Hour Blood Pressure
Time frame: The morning of day 9 through the morning of day 10 for each arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Edwards, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Sodium in people with Sodium Excess, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David G Edwards, PhD (302-831-3363, dge@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflected Pulse Wave Amplitude (time frame: On the 10th day of each arm.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.