Salt Intake, Microbiota, Immune Response and Endothelial Function in Hypertension

NCT ID: NCT04648592

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-04-30

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Low salt diet plus sodium chloride supplements

Intervention Type: DIETARY_SUPPLEMENT

Patients will receive a low salt diet plus salt supplements.

Control

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.

Group Type: PLACEBO_COMPARATOR

Low salt diet plus placebo

Intervention Type: DIETARY_SUPPLEMENT

Patients will receive a low salt diet plus placebo.

Interventions

Low salt diet plus sodium chloride supplements

Patients will receive a low salt diet plus salt supplements.

Intervention Type: DIETARY_SUPPLEMENT

Low salt diet plus placebo

Patients will receive a low salt diet plus placebo.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Salt; Placebo

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years.
• Diagnosis of primary hypertension on treatment for at least 12 months with an ACEI or ARB-II in monotherapy.
• Able to understand the study objectives and to provide written informed consent.

Exclusion Criteria

• Severe hypertension, defined as a sitting systolic blood pressure ≥200 mmHg, a sitting diastolic blood pressure ≥115 mmHg or a maximum-minimum difference of ≥20 mmHg in systolic blood pressure or ≥10 mmHg in diastolic blood pressure between the right and left arms after three measurements on each arm.
• Suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age <30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly,
• Treated with antihypertensive drugs other than ACEIs or ARBs.
• Use of drugs that affect diuresis or natriuresis.
• Poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or HbA1c ≥9%.
• History of cardiovascular disease, defined as acute myocardial infarction, ischemic transient attack or stroke, congestive heart failure, peripheral vascular disease or cardiac arrhythmias.
• Chronic obstructive pulmonary disease.
• Liver or kidney disease.
• Pregnant or lactating women.
• Legal incapacity or impossibility to understand the study objectives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Armando Coca Rojo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armando Coca, MD, MSc, phD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Valladolid

Locations

Hospital Clínico Universitario

Valladolid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Armando Coca, MD, MSc, phD

Role: CONTACT

a.coca.rojo@gmail.com

983420000

Facility Contacts

Armando Coca, MD, PhD

Role: primary

a.coca.rojo@gmail.com

630841439

Other Identifiers

PI 19-1342

Identifier Type: -

Identifier Source: org_study_id