The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2019
CompletedFirst Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2021
CompletedOctober 2, 2023
September 1, 2023
1.9 years
January 13, 2020
September 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
High Salt
EXPERIMENTALSubjects 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.
Recommended Salt
PLACEBO COMPARATORSubjects will be counseled to consume a diet with 2,300 mg/d sodium which they will supplement with placebo pills.
Interventions
Consumption of pills containing dextrose for 10 days.
Eligibility Criteria
You may qualify if:
- healthy
- normal blood pressure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Delaware
Newark, Delaware, 19716, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon L Lennon, PhD, RD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blinded
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
April 16, 2019
Primary Completion
February 24, 2021
Study Completion
February 24, 2021
Last Updated
October 2, 2023
Record last verified: 2023-09