Clinical Trials Directory

Trials / Completed

CompletedNCT04229680

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
University of Delaware · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERHigh SaltConsumption of pills containing table salt for 10 days.
OTHERRecommended SaltConsumption of pills containing dextrose for 10 days.

Timeline

Start date
2019-04-16
Primary completion
2021-02-24
Completion
2021-02-24
First posted
2020-01-18
Last updated
2023-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04229680. Inclusion in this directory is not an endorsement.