NCT05970601

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

Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function and Immune Response - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Prof. Dr. med. Johannes Stegbauer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soup	Intake of a single soup with different sodium chloride and potassium chloride content

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-03-22
• Completion: 2024-09-30
• First posted: 2023-08-01
• Last updated: 2025-02-04

Locations

1 site across 1 country: Germany