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

NCT04648592 | Unknown

• 1 other identifier: PI 19-1342
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension; Salt intake

Outcome Measures

Primary Outcomes (1)

• Absolute change in lymphocyte subset counts

  Lymphocyte subset counts

  30 days

Secondary Outcomes (4)

• Relative change in gut microbiota composition daily total salt

  30 days

• Relative change in body composition assessed by electrical bioimpedance

  30 days

• Absolute change in peak and average 24h ambulatory blood pressure measurement

  30 days

• Absolute change in endothelial function

  30 days

Study Arms (2)

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.

Dietary Supplement: Low salt diet plus sodium chloride supplements

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.

Dietary Supplement: Low salt diet plus placebo

Interventions

Low salt diet plus sodium chloride supplements DIETARY_SUPPLEMENT

Patients will receive a low salt diet plus salt supplements.

Also known as: Salt

Intervention

Low salt diet plus placebo DIETARY_SUPPLEMENT

Patients will receive a low salt diet plus placebo.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario

Valladolid, 47003, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted; Salts

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Inorganic Chemicals

Study Officials

• Armando Coca, MD, MSc, phD

  Hospital Clínico Universitario Valladolid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Coca, MD, MSc, phD

CONTACT

983420000; a.coca.rojo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Trial participants, care providers and study investigators will be blinded to assigned interventions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, double blind clinical trial.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: April 30, 2022
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)