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NCT Number: NCT06968182

The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects.

The study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. After the treatment the subjects went to an examination day. With 1 L isotonic sodium chlorid intravenous in 25 minutes, the subjects were further sodium and volume loaded. Change in salt blood test (SaBT), syndecan-1(syn-1) and heparan sulfate (HS), brachial and central blood pressure (BP), pulse wave velocity (PWV) and augmentation index (AIx) were measured. Baseline blood samples were taken before the treatment periods

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Key information

Conditions

Sodium Blood Pressure Renal Function

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background: The endothelium is lined with endothelial glycocalyx (EG). EG protects the endothelium and functions as a barrier between blood and endothelium. Due to negative charges EG has a strong ability to buffer sodium. In vitro studies indicate that sodium overload can damage the EG and reduce the sodium buffer capacity. This could cause endothelial dysfunction and might lead to cardiovascular disease. EG can be measured by the erythrocyte salt sensitivity (ESS) and shedding of glycocalyx.

Purpose: The investigators aimed to examine the effect of dietary sodium balance on EG in healthy subjects.

Methods: In a double blinded, randomized, placebo controlled cross over study, 27 healthy subjects received a four days sodium reduced diet and treatment with NaCl or placebo in randomized order. Afterwards the subjects were further sodium and volume loaded with 1 L isotonic NaCl intravenously. Changes in ESS and blood pressure were measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Both gender
  • Age 18-50 years,
  • BMI 18.5-30.0 kg/m2,
  • Signed concent.
  • Fertile women with safe contraception during the whole examination period.

Exclusion criteria

  • Alcohol consumption > 7 drinks per week for women and, > 14 drinks per week for men.
  • Smoking,
  • Substance abuse
  • Current use of medicine except contraception,
  • Office BP > 140/90
  • History or signs of clinically relevant kidney, heart, liver, lung, neurological, or endocrine diseases, neoplastic disorders,
  • Pregnancy or lactation
  • Blood donation within 1 month of the first investigation,
  • Clinically relevant abnormal blood/urine sample or electrocardiography.

Withdrawal criteria:

  • Development of exclusion criteria
  • Suspicion of poor compliance to study medication
  • Withdrawal of signed concent.

Treatment and study plan

Sodium chloride

Dietary Supplement

During the examination day after a baseline period, from 11.00 AM to 11.30 AM, a sustained infusion of 1 L isotonic NaCl, was administered.

Primary outcomes

  1. erythrocyte salt sensitivity (ESS)

    Time frame: From enrollment and at the end of the second examination day, aprox. 3-4 months

    eGC is in dynamic equilibrium between biosynthesis of new components and release of "old". This is called shedding and the protein components can be measured in the plasma. Shedding is increased in e.g. sepsis, ischemia, kidney failure and severe bleeding {{38 Mulivor,A.W. 2004; 36 Salmon, Andrew H J AH 2012; 48 Sillesen,M. 2014; 49 Nelson,A. 2008; 50 Steppan,J. 2011}}{{35 Nieuwdorp,M. 2005}}.

    The erythrocytes (RBC) also posses a glycocalyx-layer. Intact glycocalyx of both endothelium and erythrocytes is important for maintenance of electrostatic forces and frictionless passage of the RBC through the capillaries{{20 Oberleithner,H. 2013; 26 Oberleithner,H. 2012; 7 Oberleithner,H. 2015}} Deterioration of eGC affect the RBC, and the surface of the RBC becomes a mirror image of the properties of eGC{{20 Oberleithner,H. 2013; 8 Oberleithner,H. 2014}}.

    Change in the RBC membrane can be demonstrated by a "salt-blood test-mini"{{18 Oberleithner,H. 2013; 99 Oberleithner,H. 2016}}. This is an

Sponsors and collaborators

Lead sponsor

Frank Mose

Other

Collaborators

  • Region MidtJylland Denmark

Registry information

Official study title

The Effect of Sodium on Erythrocyte Salt Sensitivity, Syndecan-1 and Heparin Sulfate in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study

Acronym: EGNA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2025
Registry last updated
May 25, 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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