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Salt's secret role: could your immune system be driving blood pressure?

NCT ID NCT04258332

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study investigates how a high-salt diet versus a low-salt diet influences blood pressure and the immune system in middle-aged adults. Participants follow each diet for one week while their blood pressure and inflammatory markers are measured. The goal is to understand why some people's blood pressure is sensitive to salt and whether inflammation plays a key role.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High salt diet and low salt diet
What this could lead to
If successful, this could lead to a simple way to identify who is salt-sensitive and inform future treatments for high blood pressure.
What could go wrong
This is an observational study, not a treatment trial. Results may not lead to immediate clinical changes, and individual responses to salt vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

281 people

The number who actually took part.

Started

May 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Potentially eligible individuals must consent to and be willing to adhere to the study protocol. We will include individuals not taking anti-HTN medications, i.e. normotensives and untreated hypertensives, and individuals with controlled HTN by use of ≤ 3 anti-HTN medications. Exclusion Criteria: * Unwilling to adhere to the study protocol * Resistant HTN, defined as taking ≥ 4 anti-HTN medications to control BP or uncontrolled BP despite ≥ 3 anti-HTN medications that includes a diuretic * Contraindications to high- or low-salt diet (e.g. heart, renal, or liver failure, postural orthostatic tachycardia syndrome) * Use of salt tabs, fludricortisone, midodrine * Contraindications to 24hr ABPM: bilateral upper extremity lymphedema, cuff will not fit * Medical contraindications to foods, e.g. celiac disease, nut allergy, egg allergy, etc. * Year 35 core exam systolic BP \< 90 or \> 160 mm Hg or diastolic BP \< 50 or \> 100 mm Hg * Current use of steroids, NSAIDS, anti-inflammatories * Rheumatologic condition (e.g. Lupus, Rheumatoid Arthritis, Psoriatic arthritis, Inflammatory Bowel Disease, Multiple Sclerosis * Immune deficiency or immunosuppressed

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Salt-sensitivity of blood pressure

Contacts and locations

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

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