HypertensionNCT03558022
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
A study testing Salt Pills in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Salt Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 5 Nov 2021
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normotensive blood pressure (Systolic <120 AND Diastolic <80
- free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease
- non-obese (BMI <30 and/or Body fat < 25% for men, and < 30% for women)
- no tobacco use
- no medications that could affect vascular function or oxidative stress
- not sedentary
Who cannot join
- individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function
- subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible
- subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies
- pregnant women, prisoners, and children will not be eligible for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.
Read the detailed description
Sodium intake is a major contributor to the development of hypertension in the developed world. Interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals. While the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise. Therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. The investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads. Furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.
- Conditions
- Hypertension
- Being tested
- Salt Pills, Placebo Pills
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt PillsDietary supplement
7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)
Placebo PillsDietary supplement
7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals
| Study group | Role | What they receive |
|---|---|---|
| Salt Pills | Experimental | One week on low salt diet plus salt pills Receives: Dietary Supplement: Salt Pills |
| Placebo Pills | Placebo comparator | One week on low salt diet plus placebo pills Receives: Dietary Supplement: Placebo Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Dilation in Response to Exercise
Percent change is arterial diameter when compared to baseline
Measured: After 7 day high salt supplementation vs After 7 day low salt supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start15 May 2018
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Garten, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558022
- Sponsor's protocol ID
- HM20013060
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2018
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
- ClinicalTrials.gov ID
- NCT03558022
- Acronym / sponsor ID
- HM20013060
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 15 Jun 2018 (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.
The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.
Detailed description
Sodium intake is a major contributor to the development of hypertension in the developed world. Interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals. While the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise. Therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. The investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads. Furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt Pills | Experimental | Dietary Supplement: Salt PillsOne week on low salt diet plus salt pills |
| Placebo Pills | Placebo comparator | Dietary Supplement: Placebo PillsOne week on low salt diet plus placebo pills |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- normotensive blood pressure (Systolic <120 AND Diastolic <80
- free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease
- non-obese (BMI <30 and/or Body fat < 25% for men, and < 30% for women)
- no tobacco use
- no medications that could affect vascular function or oxidative stress
Key exclusion criteria (4 listed)
- individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function
- subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible
- subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies
- pregnant women, prisoners, and children will not be eligible for this study
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 |
|---|---|---|
| Salt Pills7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day) | Dietary supplement | Salt Pills |
| Placebo Pills7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals | Dietary supplement | Placebo Pills |
Primary outcome
Arterial Dilation in Response to Exercise
Time frame: After 7 day high salt supplementation vs After 7 day low salt supplementation
Percent change is arterial diameter when compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.
Ryan Garten, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt Pills in people with Hypertension, run by Virginia Commonwealth University 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Dilation in Response to Exercise (time frame: After 7 day high salt supplementation vs After 7 day low salt supplementation). 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 13 Jan 2023.