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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.

NCT07790900 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-27

No results posted yet for this study

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). 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

Conditions

  • Salt-sensitivity of Blood Pressure

Interventions

OTHER

Dietary sodium

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2031-03-01
Completion
2031-09-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790900 on ClinicalTrials.gov