Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function

NCT ID: NCT05970601

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2024-09-30

Brief Summary

This is a prospective, monocentric, randomized trial to investigate how sodium chloride or its substitute potassium chloride acutely affects vascular function by ingestion via a salted soup. Furthermore we want to get insights on the pathophysiology by analyzing metabolism and cell function in relation to vascular reaction.

Detailed Description

Some of the leading death causes in western countries are attributed to artheriosclerosis with its consequences especially cardiovascular events. Beside lifestyle risk factors such as physical inactivity, adipositas and stress, high dietary sodium intake is one of the easiest modifiable factors to reduce development and progession of artheriosclerosis. Unfortunately high sodium diet is one of the hallmarks of western diet. Epidemiologic and experimental data have provided compelling evidence that high salt and its induced elevation in bloodpressure is an important factor in the development and progression of cardiovascular disease, artheriosclerosis with its endorgan failure.

To analyze the reasons for the hazardous effects of high oral sodium chloride exposure on vascular damage and a possible protective mechanism by the salt substitute potassium chloride, we intend to conduct a single-center randomized trial (ESCAPE-SALT). We aim to measure vascular function by flow mediated dilation (FMD) and dynamic vessel analysis (DVA) of retinal mircocirculation. Participants will be divided into 3 groups. Each group will be served a soup with different salt content. The salt composition is as follows: soup A (9 g sodium chloride), soup B (6 g sodium chloride plus 3 g potassium chloride), and soup C (6 g sodium chloride). The effects on blood pressure, body composition markers, electrolytes, inflammatory and metabolic response, and vascular function are measured before, 4 and 24 h after ingestion of the soup. Furthermore we will investigate the underlying mechanism by performing metabolomic, transcriptomic and proteomic anyalysis.

Conditions

Vascular Function; Healthy; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

high salt group

Intake of 9 g sodium chloride

Group Type: EXPERIMENTAL

Soup

Intervention Type: DIETARY_SUPPLEMENT

Intake of a single soup with different sodium chloride and potassium chloride content

low salt group

Intake of 6 g sodium chloride

Group Type: ACTIVE_COMPARATOR

Soup

Intervention Type: DIETARY_SUPPLEMENT

Intake of a single soup with different sodium chloride and potassium chloride content

substitution group

Intake of 6 g sodium chloride plus 3 g potassium chloride

Group Type: ACTIVE_COMPARATOR

Soup

Intervention Type: DIETARY_SUPPLEMENT

Intake of a single soup with different sodium chloride and potassium chloride content

Interventions

Soup

Intake of a single soup with different sodium chloride and potassium chloride content

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• full-aged
• signed informed consent
• no dietary restrictions
• access to retina for microvascular measurement

Exclusion Criteria

• age <18 y
• no retinal access for microvascular measurement
• known glaucoma
• antibiotic therapy within the last 4 weeks
• immunosuppressive Therapie within the last 4 weeks (e.g. glucocorticoids)
• s.p. malignancy
• unknown fever within the last 4 weeks
• salt wasting syndroms (e.g. renal tubular acidosis, Diabetes insipidus)
• chronic kidney disease stage 4-5
• known electrolyte disorder (e.g. hyperkalaemia, hypokalaemia, hypernatriaemia, hyponatriaema)
• no or rejected informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dr. med. Johannes Stegbauer

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Johannes Stegbauer

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johannes Stegbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine University, Duesseldorf

Locations

University Hospital Düsseldorf, Heinrich Heine University

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

2022-1844

Identifier Type: -

Identifier Source: org_study_id