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Dietary Sodium for Salt Sensitivity

(Gut-SSBP Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must not be taking: Antihypertensives, Steroids, NSAIDs, Antibiotics
Disqualifiers: Heart failure, Renal failure, Liver failure, Rheumatologic conditions, Severe mental illness, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

This trial is for adults aged 50-70 who eat all types of food and are willing to follow a high- and low-salt diet. People with certain autoimmune diseases, digestive issues, severe illnesses, allergies to study foods, abnormal blood pressure, or those taking specific medications can't join.

Inclusion Criteria

Willing to adhere to the study protocol
I am between 50 and 70 years old.
Omnivore
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Exclusion Criteria

I have an autoimmune or rheumatologic condition like Lupus or Rheumatoid Arthritis.
I am not willing to change my diet or follow the study rules.
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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants undergo a randomized crossover design with one week of high-salt diet followed by one week of low-salt diet, or vice versa

2 weeks
3 visits (in-person), each 1 week apart

Sample Collection and Monitoring

Repeated stool, urine, and blood samples are collected to determine relationships between gut microbiota, SSBP, microbial and host metabolism, and inflammation

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dietary sodium

Trial Overview

The study tests how switching between high- and low-salt diets affects gut bacteria, metabolism, inflammation, and salt sensitivity of blood pressure. Participants try each diet for one week in random order while their blood pressure is closely monitored.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Low-salt then high-salt dietExperimental Treatment1 Intervention
Group II: High-salt then low-salt dietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

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