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| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-351-15 | Other Identifier | De Videnskabsetiske Komiteer For Region Midtjylland |
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| Name | Class |
|---|---|
| Region MidtJylland Denmark | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High sodium | Active Comparator | During the high sodium period, the subjects received 200 mmol sodium in tablets. The standardized sodium reduced diet contained 100 mmol sodium. |
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| Low sodium | Placebo Comparator | During the low sodium period, the subjects received the placebo tablets contained 86 mg of potato starch and 85 mg lactose monohydrate. The standardized sodium reduced diet contained 100 mmol sodium. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| erythrocyte salt sensitivity (ESS) | 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 | From enrollment and at the end of the second examination day, aprox. 3-4 months |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper N. Bech, professor | University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Hospitalsparken 15, 7400 Herning, Denmark | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40827100 | Derived | Ostergaard AM, Sonderbaek RL, Vrist MH, Rosenbaek JB, Mose FH, Bech JN. Effect of sodium balance on levels of nitrates in healthy subjects: Posthoc analysis of a randomized, double-blinded, placebo-controlled, crossover study. Physiol Rep. 2025 Aug;13(16):e70512. doi: 10.14814/phy2.70512. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Design The study was conducted as a randomized, double-blinded, placebo-controlled, crossover trial. Subjects received a four days standardized and sodium reduced diet and NaCl tablets or placebo in random order. Each treatment period was followed by an examination day. The examination days were separated by a wash-out period of at least three weeks.
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| D017670 |
| Sodium Compounds |