Salt and Gut Study
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: High Blood Pressure
In brief
High sodium intake is a significant risk factor for hypertension. Recently, animal studies connect high sodium intake to the gut-immune axis and highlight the gut microbiome as a potential therapeutic target to counteract salt-sensitive conditions and hypertension. The objective of this project is to determine the effects of high salt intake on gut microbiota composition and gut intestine barrier integrity, leading to increased BP in humans. The investigators also hypothesize that high salt intake affects the gut microbiome in a sex-specific manner. In this pilot study, The investigators also test whether telehealth or in-person nutritional coaching help to decrease dietary sodium intake and improve diet quality
Key facts
- Study ID
- NCT04958148
- Run by
- Augusta University
- People needed
- 40
- Starts
- 2020-12-18
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2021-07-12
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aged between 18-50 years
- African Americans (AAs) or European Americans (EAs)
- BP <140/90 mmHg
- Not on any prescription medications
- Normal kidney function (eGFR ≥ 90 ml/min/1.73 m2)
You may not qualify if…
- Pregnant or nursing
- Previous diagnosis of major cardiovascular diseases including myocardial infarction, congestive heart failure or stroke, diabetes, autoimmune, chronic liver and kidney disease
- Previous diagnosis of Crohn's disease or any other intestinal conditions
- Previous diagnosis of major lung diseases such as chronic obstructive pulmonary disease (COPD)
- Previous diagnosis of cancer
- Alcohol and drug abuse.
Where it is running
- Georgia Prevention Institute/ Augusta University — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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