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Hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. Salt intake is essential in the development and progression of hypertension. A reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. The mechanisms involved in the association between salt intake and blood pressure are a topic of discussion. Increased salt intake can modify cardiovascular function, inducing endothelial dysfunction, modyfing the activity of the immune system and increasing inflammation or oxidative stress.
In recent years, dietary salt intake has been linked to intestinal depletion of certain genera of bacteria such as Lactobacillus. Tryptophan metabolites formed by these bacteria have been shown to modulate the activity of pro-inflammatory cells such as Th17/CD4+, interleukin 17a producing cells. Studies in animal models have demonstrated that interleukin 17a is able to raise blood pressure by hindering endothelium-dependent vasodilation mechanisms. It is also able to cause sodium and water retention, increase albuminuria, induce renal microvascular injury and vasoconstriction and promote vascular stiffening, cardiac hypertrophy and fibrosis.
The main objective of this trial is to describe the relationship between salt intake, gut commensal microbiota, Th17 activity, endothelial dysfunction and blood pressure evolution in a sample of patients with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Low salt diet, aiming at a daily sodium intake of 50 mmol plus oral salt supplements (9 grams) to achieve an overall daily sodium intake of 200 mmol. |
|
| Control | Placebo Comparator | Low salt diet, aiming at a daily sodium intake of 50 mmol plus oral placebo supplements to achieve an overall daily sodium intake of 50 mmol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low salt diet plus sodium chloride supplements | Dietary Supplement | Patients will receive a low salt diet plus salt supplements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in lymphocyte subset counts | Lymphocyte subset counts | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in gut microbiota composition daily total salt | Taxonomic metagenomic analysis, analyzing the composition at the level of family, genus and species. Percentage of variation of each species in each control. | 30 days |
| Relative change in body composition assessed by electrical bioimpedance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armando Coca, MD, MSc, phD | Contact | 983420000 | a.coca.rojo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Armando Coca, MD, MSc, phD | Hospital ClÃnico Universitario Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario | Recruiting | Valladolid | 47003 | Spain |
Study data will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| D012492 | Salts |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Prospective, randomized, double blind clinical trial.
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Trial participants, care providers and study investigators will be blinded to assigned interventions.
| Low salt diet plus placebo | Dietary Supplement | Patients will receive a low salt diet plus placebo. |
|
|
Percentage of change in total body water, total intracellular water, total extracellular water, fat mass, percentage of fat, lean mass, and muscle-skeletal mass. |
| 30 days |
| Absolute change in peak and average 24h ambulatory blood pressure measurement | 24h ambulatory blood pressure measurement | 30 days |
| Absolute change in endothelial function | Pulse wave velocity analysis | 30 days |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D007287 | Inorganic Chemicals |