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Gut Microbiome, Metabolome, and SSBP

ConditionSalt-sensitivity of Blood Pressure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorVanderbilt University Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 50 years and ≤ 70 years.

Omnivore.

Willing to adhere to the study protocol.

Able to provide written consent.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dietary sodium

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: High-salt then low-salt dietOther 1 intervention
Group B: Low-salt then high-salt dietOther 1 intervention

Trial outcomes

Primary outcomes

1

Salt sensitivity of blood pressure

Mean arterial pressure from 24 hour ambulatory pressure monitoring, calculated as MAP (high-salt) - MAP (low-salt)

Time frame
2 weeks

Secondary outcomes

1

Prevotella

The difference in abundance of Prevotella bacteria in stool samples between the high and low salt diet weeks

Time frame
2 weeks
2

Firmicutes

The difference in abundance of Firmicutes bacteria in stool samples between the high and low salt diet weeks

Time frame
2 weeks
3

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

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: