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Completed

NCT Number: NCT05970601

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

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.

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Key information

Conditions

Vascular Function Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Düsseldorf, Heinrich Heine University

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soup

Dietary Supplement

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

Primary outcomes

  1. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on retinal vessel diameter and the flicker-light-induced retinal vessel dilatation.

    Time frame: Baseline, 4 hours, 24 hours

    Flicker-induced dilatation and diameter of fundus vessels will be measured via funduscopy in a static an dynamic analysis before, 4 hours and 24 hours after ingestion of a salty soup and the change between the timepoints will be analyzed. First the diameter of venoles and arterioles in µm and their ratio are measured in a standardized fundus picture. In a second step we will film the fundus during three flicker-light periods of 20 seconds and measure the dilatation in percent during the flicker period.

  2. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on hypoxia-induced dilatation of brachial artery.

    Time frame: Baseline, 4 hours, 24 hours

    Flow mediated dilatation (FMD) as a marker for macrovascular function will be measured at baseline, 4 hours and 24 hours after ingestion of a salty soup. We will measure FMD by ultrasound based measurement of brachial artery diameter in mm before and after induced hypoxia for 5 minutes. The change of dilatation in percentage between the different timepoints will be analyzed.

Secondary outcomes

  1. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on mitochondrial respiration capacity in PBMC.

    Time frame: Baseline, 4 hours, 24 hours

    Analysis of mitochondrial respiration capacity via seahorse technology in isolated PBMC from baseline, 4 and 24 hours after salt intake. The oxygen consumption rate (OCR) will be measured and the changes between the timepoints will be analyzed.

  2. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on NO metabolism in serum and red blood cells.

    Time frame: Baseline, 4 hours, 24 hours

    We will measure the amount of nitrite and nitrate in red blood cells and serum by gas chemiluminescence at baseline, 4 and 24 hours after salt intake. The change between the three timepoints will be measured.

  3. Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolic profile in PBMC and plasma.

    Time frame: Baseline, 4 hours, 24 hours

    We will investigate the effect of a single oral high-sodium chloride load or a partial substitution by potassium on the metabolic profile in PBMCs and theplasma. The metabolites will be measured by liquid chromotagraphy and high resolution tandem mass spectrometry at baseline, 4 hours and 24 hours after salt intake. The difference between the timepoints will be analyzed.

  4. Effect of a single oral high-sodium chloride load or a partial substitution by potassium on systemic inflammation markers.

    Time frame: Baseline, 4 hours, 24 hours

    Inflammatory markers such as cytokines will be meassured at baseline, 4 and 24 hours after salt intake by ELISA and OLINK. Changes of these markers between the three timepoints will be analyzed.

Other outcomes

  1. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on fluid body composition.

    Time frame: Baseline, 4 hours, 24 hours

    Analysis of fluid body composition and intra- and extracellular water amount by bioimpendance monitoring at baseline, 4 and 24 hours after salt intake. The changes in body composition between the three timepoints will be measured.

  2. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on blood pressure.

    Time frame: Baseline, 4 hours, 24 hours

    Analysis of blood pressure by automated office blood pressure device at baseline, 4 hours and 24 hours after salt intake. The changes in blood pressure between the three timepoints will be measured.

  3. Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on renin-angiotensine-aldosterone system.

    Time frame: Baseline, 4 hours, 24 hours

    Analysis of renin, angiotensine and aldosterone levels at baseline, 4 hours and 24 hours after salt intake, measurement will be done in the clinical routine laboratory and the difference between timepoints will be analyzed.

  4. Effect of a single oral high-sodium chloride load or a partial substitution by potassium on fecal microbiome.

    Time frame: up to 48 hours before and after salt intake

    Analysis of the change of fecal microbiome composition in microbiology of probes before and after salt intake.

  5. Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolomics in stool.

    Time frame: up to 48 hours before and after salt intake

    Analysis of the change of metabolomics in stool and serum after salt intake using liquid chromotagraphy and high resolution tandem mass spectrometry.

Sponsors and collaborators

Lead sponsor

Prof. Dr. med. Johannes Stegbauer

Other

Registry information

Official study title

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

Acronym: ESCAPE-SALT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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