Vascular FunctionESCAPE-SALTNCT05970601
Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function
A study testing Soup in people with Vascular Function and Healthy, run by Prof. Dr. med. Johannes Stegbauer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Function, Healthy, Diabetes
- What is being tested?
- Soup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full-aged
- signed informed consent
- no dietary restrictions
- access to retina for microvascular measurement
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Düsseldorf, Heinrich Heine University
Düsseldorf, 40225
About this study
Official title: Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function and Immune Response - a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Soup
- Keywords
- potassium chloride, sodium chloride, microcirculation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoupDietary supplement
Intake of a single soup with different sodium chloride and potassium chloride content
| Study group | Role | What they receive |
|---|---|---|
| high salt group | Experimental | Intake of 9 g sodium chloride Receives: Dietary Supplement: Soup |
| low salt group | Active comparator | Intake of 6 g sodium chloride Receives: Dietary Supplement: Soup |
| substitution group | Active comparator | Intake of 6 g sodium chloride plus 3 g potassium chloride Receives: Dietary Supplement: Soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline, 4 hours, 24 hours
Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on hypoxia-induced dilatation of brachial artery.
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.
Measured: Baseline, 4 hours, 24 hours
Secondary outcomes (4)
Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on mitochondrial respiration capacity in PBMC.
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.
Measured: Baseline, 4 hours, 24 hours
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.
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.
Measured: Baseline, 4 hours, 24 hours
Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolic profile in PBMC and plasma.
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.
Measured: Baseline, 4 hours, 24 hours
Effect of a single oral high-sodium chloride load or a partial substitution by potassium on systemic inflammation markers.
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.
Measured: Baseline, 4 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Aug 2023
- Primary completion22 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Johannes Stegbauer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Johannes Stegbauer, Heinrich-Heine University, Duesseldorf
- Investigators
- Johannes Stegbauer, MD, Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970601
- Sponsor's protocol ID
- 2022-1844
- Acronym
- ESCAPE-SALT
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function and Immune Response - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05970601
- Acronym / sponsor ID
- ESCAPE-SALT / 2022-1844
- Conditions
- Vascular Function, Healthy, Diabetes
- Keywords
- potassium chloride, sodium chloride, microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Prof. Dr. med. Johannes StegbauerUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high salt group | Experimental | Dietary Supplement: SoupIntake of 9 g sodium chloride |
| low salt group | Active comparator | Dietary Supplement: SoupIntake of 6 g sodium chloride |
| substitution group | Active comparator | Dietary Supplement: SoupIntake of 6 g sodium chloride plus 3 g potassium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- full-aged
- signed informed consent
- no dietary restrictions
- access to retina for microvascular measurement
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoupIntake of a single soup with different sodium chloride and potassium chloride content | Dietary supplement | high salt group, low salt group, substitution group |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Vascular Function
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Stegbauer, MD principal investigator
Heinrich-Heine University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soup in people with Vascular Function and Healthy, run by Prof. Dr. med. Johannes Stegbauer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline, 4 hours, 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.