Clinical trial NCT05970601: Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function
Official title: Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function and Immune Response - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Function
Healthy
Diabetes
Keywords: potassium chloride
sodium chloride
microcirculation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on hypoxia-induced dilatation of brachial artery.
timeFrame: Baseline, 4 hours, 24 hours
Secondary outcomes:
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on mitochondrial respiration capacity in PBMC.
timeFrame: Baseline, 4 hours, 24 hours
measure: 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.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolic profile in PBMC and plasma.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium on systemic inflammation markers.
timeFrame: Baseline, 4 hours, 24 hours
Other outcomes:
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on fluid body composition.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on blood pressure.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on renin-angiotensine-aldosterone system.
timeFrame: Baseline, 4 hours, 24 hours
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium on fecal microbiome.
timeFrame: up to 48 hours before and after salt intake
measure: Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolomics in stool.
timeFrame: up to 48 hours before and after salt intake
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Heinrich Heine University
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Johannes Stegbauer, MD
role: PRINCIPAL_INVESTIGATOR
References: