Clinical trial NCT04229680: The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota
Official title: The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Dietary sodium
Gut microbiota
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete each arm.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gut microbiota diversity
timeFrame: On day 10
measure: T cell profile
timeFrame: On day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Shannon L Lennon, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: