Salt-sensitivity of Blood PressureGut-SSBPNCT07790900
Gut Microbiome, Metabolome, and SSBP
A study testing Dietary sodium in people with Salt-sensitivity of Blood Pressure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this interventional study is to learn if elevated Na+ alters the gut microbiota and is associated with altered metabolism, inflammation and salt sensitivity of blood pressure (SSBP). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt-sensitivity of Blood Pressure
- What is being tested?
- Dietary sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years and ≤ 70 years.
- Omnivore.
- Willing to adhere to the study protocol.
- Able to provide written consent.
Who cannot join
- Unwilling to make dietary changes or otherwise adhere to the study protocol.
- Contraindications to high- or low-salt diet (e.g. heart, renal, or liver failure, postural orthostatic tachycardia syndrome)
- Use of salt tabs, fludricortisone, or midodrine.
- Contraindications to 24-hour ambulatory blood pressure monitoring, e.g. bilateral upper extremity lymphedema.
- Medical contraindications to foods, e.g. celiac disease, nut allergy, egg allergy, etc.
- Systolic blood pressure < 90 or > 160 mm Hg or diastolic blood pressure < 50 or > 100 mm Hg at screening
Show all 10Show fewer
- Current use of anti-hypertensive medications
- Current use of oral steroids, daily NSAIDS, anti-inflammatory or immune modulating medications, probiotics, or antibiotics.
- Rheumatologic condition (e.g. Lupus, Rheumatoid Arthritis, Psoriatic arthritis, Inflammatory Bowel Disease, Multiple Sclerosis).
- Presence of acute or chronic medical conditions not generalizable to the general population (including eating disorders, cancer, severe mental illness, cognitive impairment, pregnancy or lactation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Deepak Gupta, MD, MSCI
About this study
Official title: The Gut Microbiome, Metabolome and Salt-Sensitivity of Blood Pressure
The goal of this interventional study is to learn if elevated Na+ alters the gut microbiota and is associated with altered metabolism, inflammation and salt sensitivity of blood pressure (SSBP). The main questions it aims to answer are:
- SSBP correlates with Na+-induced changes in gut microbiome composition
- Na+-induced changes in the gut microbiome and SSBP are associated with altered metabolism and with immune cell activation
- Microbiota from humans with SSBP induce inflammation and hypertension in germ-free mice.
Read more
Researchers will quantify SSBP from 24-hour ambulatory BP monitoring in a randomized crossover design, using standardized one week low- and high-salt diets.
Participants will:
- Take high- and low-salt diet each for one-week
- Complete three study visits, with each visit being 1 week apart
- Complete a 72-hour dietary log
Read the detailed description
Salt-sensitivity of blood pressure (SSBP), quantified as the change in 24-hour ambulatory mean arterial pressure (MAP) from one week of high-salt to one week of low-salt diet, is an independent predictor of death due to cardiovascular events. SSBP affects nearly 50% of the hypertensive and 25% of the normotensive population. Strong evidence indicates that reducing sodium (Na+) intake decreases blood pressure and cardiovascular events, however the precise mechanisms of how dietary Na+ contributes to BP elevation and cardiovascular disease remain unclear. The gut is the first and largest location for Na+ absorption. Studies from the investigator's group and others suggest that gut microbiota contribute to salt-induced inflammation and hypertension. In preliminary cross-sectional analyses, the investigators found that elevated dietary Na+ alters the human and mouse gut microbiome, prompting an increase in Firmicutes and genus Prevotella bacteria. These alterations are associated with higher BP and altered metabolites in humans, and predispose mice to vascular inflammation and hypertension. However, there are limited data on the effect of Na+ intervention on gut microbiome composition and function, or on the contribution of microbiota to SSBP. Thus, the investigators propose deep phenotyping of adult subjects (N=50) enrolled into a SSBP challenge study, coupled with extensive mechanistic interrogation. Briefly, the investigators will quantify SSBP from 24-hour ambulatory BP monitoring in a randomized crossover design, using standardized one week low- and high-salt diets. The investigators will collect repeated stool, urine and blood samples to determine the relationships between gut microbiota, SSBP, microbial and host metabolism, and inflammation in humans, and will conduct mechanistic research using human cells and mice. The investigator's central hypothesis is that elevated Na+ alters the gut microbiota and is associated with altered metabolism, inflammation and SSBP. The specific aims are to test the hypotheses that 1) SSBP correlates with Na+-induced changes in gut microbiome composition; 2) Na+-induced changes in the gut microbiome and SSBP are associated with altered metabolism and with immune cell activation; and 3) Microbiota from humans with SSBP induce inflammation and hypertension in germ-free mice. The proposed study examines novel hypotheses regarding the relationship between the gut microbiome and SSBP and will allow for comprehensive interrogation of multiple mechanistic pathways. Successful completion of the aims will delineate the role of gut microbiota in SSBP, identify microbiota, metabolite and immune cell markers of SSBP, and could lead to more feasible and cost-effective microbiome-based therapy for SSBP.
- Conditions
- Salt-sensitivity of Blood Pressure
- Being tested
- Dietary sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sodiumOther
To quantify salt sensitivity of blood pressure, each participant will consume a high-salt diet and a low-salt diet, with each diet lasting one week.
| Study group | Role | What they receive |
|---|---|---|
| High-salt then low-salt diet | Other | Participants will undergo high- then low-salt diet week Receives: Other: Dietary sodium |
| Low-salt then high-salt diet | Other | Participants will undergo a low- then high-salt diet week. Receives: Other: Dietary sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salt sensitivity of blood pressure
Mean arterial pressure from 24 hour ambulatory pressure monitoring, calculated as MAP (high-salt) - MAP (low-salt)
Measured: 2 weeks
Secondary outcomes (3)
Prevotella
The difference in abundance of Prevotella bacteria in stool samples between the high and low salt diet weeks
Measured: 2 weeks
Firmicutes
The difference in abundance of Firmicutes bacteria in stool samples between the high and low salt diet weeks
Measured: 2 weeks
Tumor necrosis factor alpha (TNF alpha)
The difference in supernatant levels of TNFalpha from cultured peripheral bone marrow cells between the high and low-salt diet weeks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt-sensitivity of Blood PressureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Deepak Gupta, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790900
- Sponsor's protocol ID
- 251751
- Other IDs
- 1R01HL182899-01
- Acronym
- Gut-SSBP
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiome, Metabolome and Salt-Sensitivity of Blood Pressure
- ClinicalTrials.gov ID
- NCT07790900
- Acronym / sponsor ID
- Gut-SSBP / 251751
- Conditions
- Salt-sensitivity of Blood Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 27 Aug 2026 (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 goal of this interventional study is to learn if elevated Na+ alters the gut microbiota and is associated with altered metabolism, inflammation and salt sensitivity of blood pressure (SSBP). The main questions it aims to answer are:
- SSBP correlates with Na+-induced changes in gut microbiome composition
- Na+-induced changes in the gut microbiome and SSBP are associated with altered metabolism and with immune cell activation
- Microbiota from humans with SSBP induce inflammation and hypertension in germ-free mice.
Researchers will quantify SSBP from 24-hour ambulatory BP monitoring in a randomized crossover design, using standardized one week low- and high-salt diets.
Participants will:
- Take high- and low-salt diet each for one-week
- Complete three study visits, with each visit being 1 week apart
- Complete a 72-hour dietary log
Detailed description
Salt-sensitivity of blood pressure (SSBP), quantified as the change in 24-hour ambulatory mean arterial pressure (MAP) from one week of high-salt to one week of low-salt diet, is an independent predictor of death due to cardiovascular events. SSBP affects nearly 50% of the hypertensive and 25% of the normotensive population. Strong evidence indicates that reducing sodium (Na+) intake decreases blood pressure and cardiovascular events, however the precise mechanisms of how dietary Na+ contributes to BP elevation and cardiovascular disease remain unclear. The gut is the first and largest location for Na+ absorption. Studies from the investigator's group and others suggest that gut microbiota contribute to salt-induced inflammation and hypertension. In preliminary cross-sectional analyses, the investigators found that elevated dietary Na+ alters the human and mouse gut microbiome, prompting an increase in Firmicutes and genus Prevotella bacteria. These alterations are associated with higher BP and altered metabolites in humans, and predispose mice to vascular inflammation and hypertension. However, there are limited data on the effect of Na+ intervention on gut microbiome composition and function, or on the contribution of microbiota to SSBP. Thus, the investigators propose deep phenotyping of adult subjects (N=50) enrolled into a SSBP challenge study, coupled with extensive mechanistic interrogation. Briefly, the investigators will quantify SSBP from 24-hour ambulatory BP monitoring in a randomized crossover design, using standardized one week low- and high-salt diets. The investigators will collect repeated stool, urine and blood samples to determine the relationships between gut microbiota, SSBP, microbial and host metabolism, and inflammation in humans, and will conduct mechanistic research using human cells and mice. The investigator's central hypothesis is that elevated Na+ alters the gut microbiota and is associated with altered metabolism, inflammation and SSBP. The specific aims are to test the hypotheses that 1) SSBP correlates with Na+-induced changes in gut microbiome composition; 2) Na+-induced changes in the gut microbiome and SSBP are associated with altered metabolism and with immune cell activation; and 3) Microbiota from humans with SSBP induce inflammation and hypertension in germ-free mice. The proposed study examines novel hypotheses regarding the relationship between the gut microbiome and SSBP and will allow for comprehensive interrogation of multiple mechanistic pathways. Successful completion of the aims will delineate the role of gut microbiota in SSBP, identify microbiota, metabolite and immune cell markers of SSBP, and could lead to more feasible and cost-effective microbiome-based therapy for SSBP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-salt then low-salt diet | Other | Other: Dietary sodiumParticipants will undergo high- then low-salt diet week |
| Low-salt then high-salt diet | Other | Other: Dietary sodiumParticipants will undergo a low- then high-salt diet week. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years and ≤ 70 years.
- Omnivore.
- Willing to adhere to the study protocol.
- Able to provide written consent.
Key exclusion criteria (10 listed)
- Unwilling to make dietary changes or otherwise adhere to the study protocol.
- Contraindications to high- or low-salt diet (e.g. heart, renal, or liver failure, postural orthostatic tachycardia syndrome)
- Use of salt tabs, fludricortisone, or midodrine.
- Contraindications to 24-hour ambulatory blood pressure monitoring, e.g. bilateral upper extremity lymphedema.
- Medical contraindications to foods, e.g. celiac disease, nut allergy, egg allergy, etc.
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 sodiumTo quantify salt sensitivity of blood pressure, each participant will consume a high-salt diet and a low-salt diet, with each diet lasting one week. | Other | High-salt then low-salt diet, Low-salt then high-salt diet |
Primary outcome
Salt sensitivity of blood pressure
Time frame: 2 weeks
Mean arterial pressure from 24 hour ambulatory pressure monitoring, calculated as MAP (high-salt) - MAP (low-salt)
3 secondary outcomes
Prevotella
Time frame: 2 weeks
Firmicutes
Time frame: 2 weeks
Tumor necrosis factor alpha (TNF alpha)
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sodium in people with Salt-sensitivity of Blood Pressure, run by Vanderbilt University Medical Center 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Salt sensitivity of blood pressure (time frame: 2 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 4 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.