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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229680
• Other study ID #: 1423170
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: September 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• High Salt
Consumption of pills containing table salt for 10 days.
• Recommended Salt
Consumption of pills containing dextrose for 10 days.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota diversity	The difference in gut microbiota diversity between the two arms.	On day 10
Primary	T cell profile	The difference in T regulatory and T helper 17 cells between each arm.	On day 10