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

NCT05970601 | Completed

• 1 other identifier: 2022-1844
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Function; Healthy; Diabetes

Keywords

potassium chloride; sodium chloride; microcirculation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

  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.

  Baseline, 4 hours, 24 hours

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

  Baseline, 4 hours, 24 hours

Other Outcomes (5)

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

  Baseline, 4 hours, 24 hours

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

  Baseline, 4 hours, 24 hours

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

  Baseline, 4 hours, 24 hours

Study Arms (3)

high salt group

EXPERIMENTAL

Intake of 9 g sodium chloride

Dietary Supplement: Soup

low salt group

ACTIVE COMPARATOR

Intake of 6 g sodium chloride

Dietary Supplement: Soup

substitution group

ACTIVE COMPARATOR

Intake of 6 g sodium chloride plus 3 g potassium chloride

Dietary Supplement: Soup

Interventions

Soup DIETARY_SUPPLEMENT

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

high salt group; low salt group; substitution group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Johannes Stegbauer: lead

Study Sites (1)

University Hospital Düsseldorf, Heinrich Heine University

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Johannes Stegbauer, MD

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: August 1, 2023
• Study Start: August 9, 2023
• Primary Completion: March 22, 2024
• Study Completion: September 30, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)