This Study Will Look at How Elevated Na+ Alters the Gut Microbiota, Particularly in Salt-sensitive Individuals, and is Associated With Inflammation, Metabolic Changes, and SSBP. The Study Will Examine 50 Individuals Using Randomized Crossover Trial Design.

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07790900
Status
Not Yet Recruiting

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Conditions

  • Salt-sensitivity of Blood Pressure

Eligibility Criteria

Sex
ALL
Age
50 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Dietary sodium — OTHER
    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 Details

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

Key Dates

First listed
Aug 27, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2031
Completion
Sep 1, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: High-salt then low-salt diet
    Participants will undergo high- then low-salt diet week
  • Other: Low-salt then high-salt diet
    Participants will undergo a low- then high-salt diet week.

Primary Outcome Measure

Salt sensitivity of blood pressure [ Time Frame: 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Deepak Gupta, MD, MSCI (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University Medical Center· Nashville, TN

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