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OpenTrials
Completed

NCT Number: NCT04229680

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Salt

Other

Consumption of pills containing table salt for 10 days.

Recommended Salt

Other

Consumption of pills containing dextrose for 10 days.

Other names: Placebo

Primary outcomes

  1. Gut microbiota diversity

    Time frame: On day 10

    The difference in gut microbiota diversity between the two arms.

  2. T cell profile

    Time frame: On day 10

    The difference in T regulatory and T helper 17 cells between each arm.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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