Sodium ExcessNCT04244604
Vascular Effects of Acute Sodium (VEAS) Study
A study testing Low Sodium Meal (140 mg sodium chloride) and High Sodium Meal (2500 mg sodium chloride) in people with Sodium Excess and Racial Disparities, run by Indiana University at 2 sites in United States.
Trial summary
This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium Excess, Racial Disparities, Blood Pressure
- What is being tested?
- Low Sodium Meal (140 mg sodium chloride) and High Sodium Meal (2500 mg sodium chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2021to 15 Dec 2025
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are between the ages of 19-40.
- Have blood pressure no higher than 140/90 mmHg.
- Have a BMI below 35 Kg/m2 (otherwise healthy)
- Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
- Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months.
Who cannot join
- High blood pressure - greater than 140/90 mmHg
- Obesity (BMI > 30 kg/m2)
- History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)
- Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)
- Medical issues that prevent giving blood (e.g., blood thinners)
- Currently smoking, using smokeless tobacco, or vaping (within past 12 monrths)
- Current pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Auburn University
Auburn, Alabama, 36849
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
Official title: The Effects of a High Salt Meal on Blood Flow Regulation
This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998).
About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal.
Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.
Read the detailed description
The investigators have previously used a high-sodium saline infusion to increase blood sodium and consequently increase blood pressure in Black and White individuals. The investigators' prior data suggest that increased blood sodium concentrations result in larger blood pressure elevations for a given elevation in blood sodium levels in Black compared to White adults. In this proposal, the investigators are seeking to translate these previous findings using a single high-salt meal (up to 2500 mg of sodium; similar to a few slices of pizza or a sandwich/burger and side dish). Our primary aims are to determine if the high-sodium meal causes greater 1) blood pressure dysregulation 2) decreases in blood vessel function and 3) larger changes in blood sodium in Black compared to White individuals. Other potential questions that could be determined include aging differences or an influence of fitness. The investigators will not exclude other races/ethnicities as the project will also determine the response of other minority groups (e.g. Asian or Latine/Hispanic adults) to a high-salt meal.
Participants will report to the laboratory for four visits. At the first visit, consent for study participation will be obtained and participants will be screened for eligibility. Baseline assessments will be completed which may include fitness testing and body composition assessments. If necessary, these assessments may be completed at a second in-person visit. Participants will then report to the laboratory for two experimental visits. At each visit, participants will consume a randomly assigned meal (i.e., a soup containing either low- or high-salt) and undergo assessments prior to and 30- and 60-minutes after consumption. During the study, all participants will consume both meals, however, the order of exposure will be randomly assigned.
- Being tested
- Low Sodium Meal (140 mg sodium chloride), High Sodium Meal (2500 mg sodium chloride)
- Keywords
- blood pressure, racial disparities, cardiovascular health, physical fitness, sleep, dietary sodium, dietary salt, diet
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium Meal (140 mg sodium chloride)Other
Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition.
High Sodium Meal (2500 mg sodium chloride)Other
Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition.
| Study group | Role | What they receive |
|---|---|---|
| High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium) | Experimental | On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed. Receives: Other: Low Sodium Meal (140 mg sodium chloride); Other: High Sodium Meal (2500 mg sodium chloride) |
| Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium) | Experimental | On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed. Receives: Other: Low Sodium Meal (140 mg sodium chloride); Other: High Sodium Meal (2500 mg sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure reactivity
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
Measured: Before and one hour after soup, both conditions (high- and low- salt)
Secondary outcomes (1)
Changes in flow-mediated dilation (FMD)
Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
Measured: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start3 May 2021
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sodium ExcessStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention is to provide subjects with either a low sodium meal (140 mg sodium) and a high sodium meal (2500 mg sodium), in a randomized order.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Austin Robinson, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244604
- Sponsor's protocol ID
- 23319
- Other IDs
- K01HL147998
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
Publications
Wenner MM, Paul EP, Robinson AT, Rose WC, Farquhar WB. Acute NaCl Loading Reveals a Higher Blood Pressure for a Given Serum Sodium Level in African American Compared to Caucasian Adults. Front Physiol. 2018 Oct 1;9:1354. doi: 10.3389/fphys.2018.01354. eCollection 2018.
PubMed 30327611Babcock MC, Robinson AT, Migdal KU, Watso JC, Wenner MM, Stocker SD, Farquhar WB. Reducing Dietary Sodium to 1000 mg per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow. Hypertension. 2019 Mar;73(3):587-593. doi: 10.1161/HYPERTENSIONAHA.118.12074.
PubMed 30661474Dickinson KM, Clifton PM, Burrell LM, Barrett PH, Keogh JB. Postprandial effects of a high salt meal on serum sodium, arterial stiffness, markers of nitric oxide production and markers of endothelial function. Atherosclerosis. 2014 Jan;232(1):211-6. doi: 10.1016/j.atherosclerosis.2013.10.032. Epub 2013 Nov 20.
PubMed 24401240Migdal KU, Robinson AT, Watso JC, Babcock MC, Serrador JM, Farquhar WB. A high-salt meal does not augment blood pressure responses during maximal exercise. Appl Physiol Nutr Metab. 2020 Feb;45(2):123-128. doi: 10.1139/apnm-2019-0217. Epub 2019 Jun 25.
PubMed 31238011Culver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.
PubMed 39873709
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Salt Meal on Blood Flow Regulation
- ClinicalTrials.gov ID
- NCT04244604
- Acronym / sponsor ID
- 23319
- Keywords
- blood pressure, racial disparities, cardiovascular health, physical fitness, sleep, dietary sodium, dietary salt, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Delaware, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 28 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.
This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998).
About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal.
Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.
Detailed description
The investigators have previously used a high-sodium saline infusion to increase blood sodium and consequently increase blood pressure in Black and White individuals. The investigators' prior data suggest that increased blood sodium concentrations result in larger blood pressure elevations for a given elevation in blood sodium levels in Black compared to White adults. In this proposal, the investigators are seeking to translate these previous findings using a single high-salt meal (up to 2500 mg of sodium; similar to a few slices of pizza or a sandwich/burger and side dish). Our primary aims are to determine if the high-sodium meal causes greater 1) blood pressure dysregulation 2) decreases in blood vessel function and 3) larger changes in blood sodium in Black compared to White individuals. Other potential questions that could be determined include aging differences or an influence of fitness. The investigators will not exclude other races/ethnicities as the project will also determine the response of other minority groups (e.g. Asian or Latine/Hispanic adults) to a high-salt meal.
Participants will report to the laboratory for four visits. At the first visit, consent for study participation will be obtained and participants will be screened for eligibility. Baseline assessments will be completed which may include fitness testing and body composition assessments. If necessary, these assessments may be completed at a second in-person visit. Participants will then report to the laboratory for two experimental visits. At each visit, participants will consume a randomly assigned meal (i.e., a soup containing either low- or high-salt) and undergo assessments prior to and 30- and 60-minutes after consumption. During the study, all participants will consume both meals, however, the order of exposure will be randomly assigned.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The intervention is to provide subjects with either a low sodium meal (140 mg sodium) and a high sodium meal (2500 mg sodium), in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium) | Experimental | Other: Low Sodium Meal (140 mg sodium chloride), Other: High Sodium Meal (2500 mg sodium chloride)On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed. |
| Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium) | Experimental | Other: Low Sodium Meal (140 mg sodium chloride), Other: High Sodium Meal (2500 mg sodium chloride)On experimental visit days, participants will consume each of the experimental meals, in this order. Prior to, and at several timepoints after consumption, they will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are between the ages of 19-40.
- Have blood pressure no higher than 140/90 mmHg.
- Have a BMI below 35 Kg/m2 (otherwise healthy)
- Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
Key exclusion criteria (7 listed)
- High blood pressure - greater than 140/90 mmHg
- Obesity (BMI > 30 kg/m2)
- History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)
- Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)
- Medical issues that prevent giving blood (e.g., blood thinners)
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 |
|---|---|---|
| Low Sodium Meal (140 mg sodium chloride)Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition. | Other | High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium), Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium) |
| High Sodium Meal (2500 mg sodium chloride)Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure. The Low Sodium soup will serve as the control condition. | Other | High Sodium Meal (2500 mg sodium), Then Low Sodium Meal (140 mg sodium), Low Sodium Meal (140 mg sodium), then High Sodium Meal (2500 mg sodium) |
Primary outcome
Changes in blood pressure reactivity
Time frame: Before and one hour after soup, both conditions (high- and low- salt)
The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
1 secondary outcome
Changes in flow-mediated dilation (FMD)
Time frame: Before, 30 minutes, and one hour after soup, both conditions (high- and low- salt)
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 19 Dec 2025.
- Background: PubMed 30327611Wenner MM, Paul EP, Robinson AT, Rose WC, Farquhar WB. Acute NaCl Loading Reveals a Higher Blood Pressure for a Given Serum Sodium Level in African American Compared to Caucasian Adults. Front Physiol. 2018 Oct 1;9:1354. doi: 10.3389/fphys.2018.01354. eCollection 2018.
- Background: PubMed 30661474Babcock MC, Robinson AT, Migdal KU, Watso JC, Wenner MM, Stocker SD, Farquhar WB. Reducing Dietary Sodium to 1000 mg per Day Reduces Neurovascular Transduction Without Stimulating Sympathetic Outflow. Hypertension. 2019 Mar;73(3):587-593. doi: 10.1161/HYPERTENSIONAHA.118.12074.
- Background: PubMed 24401240Dickinson KM, Clifton PM, Burrell LM, Barrett PH, Keogh JB. Postprandial effects of a high salt meal on serum sodium, arterial stiffness, markers of nitric oxide production and markers of endothelial function. Atherosclerosis. 2014 Jan;232(1):211-6. doi: 10.1016/j.atherosclerosis.2013.10.032. Epub 2013 Nov 20.
- Background: PubMed 31238011Migdal KU, Robinson AT, Watso JC, Babcock MC, Serrador JM, Farquhar WB. A high-salt meal does not augment blood pressure responses during maximal exercise. Appl Physiol Nutr Metab. 2020 Feb;45(2):123-128. doi: 10.1139/apnm-2019-0217. Epub 2019 Jun 25.
- Derived from this study: PubMed 39873709Culver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Sodium Meal (140 mg sodium chloride) and High Sodium Meal (2500 mg sodium chloride) in people with Sodium Excess and Racial Disparities, run by Indiana University at 2 sites 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 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Changes in blood pressure reactivity (time frame: Before and one hour after soup, both conditions (high- and low- salt)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244604, which also lists 5 linked publications.
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 19 Dec 2025.