The Salty Gut: Effects of High Dietary Salt Intake on the... | NCT04229680

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

NCT04229680

Sponsor

University of Delaware

Status

Completed

Last Update Posted

Oct 2, 2023Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Cardiovascular Risk Factor

Interventions

High Salt
Recommended Salt

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2019Actual

Primary Completion Date

Feb 24, 2021Actual

Completion Date

Feb 24, 2021Actual

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Jan 13, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2023

Last Update Posted Date

Oct 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Salt	Experimental	Subjects will be counseled to consume a diet with 2,300 mg/d sodium which they will supplement with pills containing salt to achieve an intake of 6,900 mg/d sodium.	Other: High Salt
Recommended Salt	Placebo Comparator	Subjects will be counseled to consume a diet with 2,300 mg/d sodium which they will supplement with placebo pills.	Other: Recommended Salt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Salt	Other	Consumption of pills containing table salt for 10 days.	High Salt

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shannon L Lennon, PhD, RD	University of Delaware	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Delaware		Newark	Delaware	19716	United States