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The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota

The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04229680
Enrollment
31
Registered
2020-01-18
Start date
2019-04-16
Completion date
2021-02-24
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Keywords

Dietary sodium, Gut microbiota

Brief summary

Gut microbiota has a role in cardiovascular disease and recent findings in rodents show dietary salt can negatively alter gut microbiota composition. High salt intake is a risk factor for cardiovascular disease. Americans consume dietary salt in excess of Dietary Guidelines and American Heart Association recommendations. The objective of this project is to investigate the influence of high dietary salt consumption on the gut microbiota composition in men and women.

Detailed description

Gut microbiota composition and function has an important role in host physiology. In general, gut microbial diversity is positively correlated with health status. Recent evidence confirms the role of gut dysbiosis in cardiovascular disease. Americans consume 50% more salt than the amount recommended by the Dietary Guidelines and 130% more than recommended by the American Heart Association. Excess salt intake is considered a modifiable risk factor for cardiovascular disease. Changes in the gut microbiota composition followed by immune system activation is reported with high salt intake in animals. In particular, abundance of proinflammatory T helper 17 (Th17) cells increases with excess salt consumption. In contrast, T regulatory (Treg) cells oppose Th17 cell action and may aid in reducing inflammation associated with high salt intake, a hypothesis that has not yet been tested in humans. Only one preliminary study assessed changes in gut bacterial composition with high salt intake in humans, when only men were recruited. The study also found an increase in Th17 cell abundance. Thus, the objective of this study is to investigate the influence of high salt intake on the gut microbiota diversity and Th17 and Treg cell abundance in men and women.

Interventions

OTHERHigh Salt

Consumption of pills containing table salt for 10 days.

OTHERRecommended Salt

Consumption of pills containing dextrose for 10 days.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Single-blinded

Intervention model description

All participants will complete each arm.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy * normal blood pressure

Exclusion criteria

* hypertension * cardiovascular disease * renal disease * diabetes * cancer * current use of anti-inflammatory agents, glucocorticoids or other immune regulating medications, or certain anti-depressants * history of intestinal surgery * inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder * antibiotic use in the past 3 months * prebiotic, probiotic, or antioxidant supplementation in the past 3 months * ≥10 lbs weight gain or loss in the past 6 months * use of tobacco products * highly trained endurance athletes * current pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota diversityOn day 10The difference in gut microbiota diversity between the two arms.
T cell profileOn day 10The difference in T regulatory and T helper 17 cells between each arm.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026