HealthyPhase 4NCT03424993
Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure
A Phase 4 study testing Dietary Sodium Restriction in people with Healthy, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Sodium Restriction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2018to 10 Jun 2024
- Phase
- Phase 4
- 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
- Habitual dietary sodium intake > 3400mg per day
Who cannot join
- Abnormal resting ECG
- Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).
- Hypertension (currently taking anti-hypertensive medications or resting blood pressure >140/90 mmHg)
- Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease
- Obesity (Body Mass Index > 30)
- Current pregnancy
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
About this study
Official title: Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study
The purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
Read the detailed description
Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have "salt sensitive" blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men \& women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
- Conditions
- Healthy
- Being tested
- Dietary Sodium Restriction, Control
- Keywords
- Endothelium, vascular, Cardiovascular Disease, Hemodynamics, Oxidative Stress, Dietary Sodium, Dietary Counseling
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Sodium RestrictionOther
A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks
ControlOther
Participants will consume their routine habitual dietary sodium intake > 3400mg per day with regular pre determined check in phone calls from a registered dietician.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Sodium Restriction | Experimental | Daily habitual dietary sodium intake < 2000mg Receives: Other: Dietary Sodium Restriction |
| Control | Sham comparator | Routine habitual dietary sodium intake >3400mg Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflected Pulse Wave Amplitude
Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.
Measured: Change from baseline at 4 weeks
Secondary outcomes (4)
Microvascular Function
Cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with intradermal microdialysis
Measured: Change from baseline at 4 weeks
Conduit Artery Endothelial Dependent Dilation
Brachial artery flow mediated dilation assessed by duplex ultrasound
Measured: Change from baseline at 4 weeks
Arterial Stiffness
Carotid - Femoral pulse wave velocity assessed by applanation tonometry
Measured: Change from baseline at 4 weeks
Forward pulse wave amplitude
Central hemodynamic assessment of the forward pulse wave amplitude assessed by echocardiography combined with applanation tonometry.
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start21 Jan 2018
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Farquhar, University of Delaware
- Investigators
- William B Farquhar, PhD, Principal investigator, University of DelawareDavid G Edwards, PhD, Principal investigator, University of DelawareShannon Lennon, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424993
- Sponsor's protocol ID
- 1083986
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2018
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effects of Dietary Salt in Humans With Salt-Resistant Blood Pressure: Dietary Counseling Study
- ClinicalTrials.gov ID
- NCT03424993
- Acronym / sponsor ID
- 1083986
- Conditions
- Healthy
- Keywords
- Endothelium, vascular, Cardiovascular Disease, Hemodynamics, Oxidative Stress, Dietary Sodium, Dietary Counseling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 7 Feb 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 purpose of this study is to determine the effects of dietary salt restriction on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
Detailed description
Cardiovascular disease remains a major Public Health problem and is the leading cause of death in the US. Dietary sodium restriction is considered an important lifestyle modification for individuals with hypertension; however, there is controversy about the effects of dietary salt given that many individuals do not have "salt sensitive" blood pressure. Deleterious effects of salt on the vasculature may explain the finding that chronic DSR reduces the cardiovascular event rate by 25%despite only minor reductions in BP. It is not known whether dietary sodium restriction improves central pulsatile hemodynamics, known to be related to the development of left ventricular hypertrophy and heart failure risk, and whether the hypothesized improvements in central hemodynamics are similar in men \& women. The purpose of this study is to determine the effects of dietary sodium restriction through dietary counseling on central hemodynamics and vascular function in men and women with salt resistant blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Sodium Restriction | Experimental | Other: Dietary Sodium RestrictionDaily habitual dietary sodium intake < 2000mg |
| Control | Sham comparator | Other: ControlRoutine habitual dietary sodium intake >3400mg |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Habitual dietary sodium intake > 3400mg per day
Key exclusion criteria (7 listed)
- Abnormal resting ECG
- Current abnormal blood panel (assessed by comprehensive metabolic panel, lipid panel and complete blood count).
- Hypertension (currently taking anti-hypertensive medications or resting blood pressure >140/90 mmHg)
- Medical history of cardiovascular disease, malignant cancer, diabetes or kidney disease
- Obesity (Body Mass Index > 30)
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 |
|---|---|---|
| Dietary Sodium RestrictionA registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks | Other | Dietary Sodium Restriction |
| ControlParticipants will consume their routine habitual dietary sodium intake > 3400mg per day with regular pre determined check in phone calls from a registered dietician. | Other | Control |
Primary outcome
Reflected Pulse Wave Amplitude
Time frame: Change from baseline at 4 weeks
Late systolic pulsatile load on the left ventricle represented by reflected pulse wave amplitude; assessed by echocardiography combined with applanation tonometry.
4 secondary outcomes
Microvascular Function
Time frame: Change from baseline at 4 weeks
Conduit Artery Endothelial Dependent Dilation
Time frame: Change from baseline at 4 weeks
Arterial Stiffness
Time frame: Change from baseline at 4 weeks
Forward pulse wave amplitude
Time frame: Change from baseline at 4 weeks
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 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
William B Farquhar, PhD principal investigator
University of Delaware
David G Edwards, PhD principal investigator
University of Delaware
Shannon Lennon, 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 Phase 4 study testing Dietary Sodium Restriction in people with Healthy, 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 7 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 28 Oct 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reflected Pulse Wave Amplitude (time frame: Change from baseline at 4 weeks). 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 28 Oct 2024.