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

NCT ID: NCT06968182

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-18
• Study Completion Date: 2017-01-13

Brief Summary

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

Detailed Description

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.

Conditions

Sodium; Renal Function; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

High sodium

During the high sodium period, the subjects received 200 mmol sodium in tablets. The standardized sodium reduced diet contained 100 mmol sodium.

Group Type: ACTIVE_COMPARATOR

Sodium Chloride

Intervention Type: 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.

Low sodium

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.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type: 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.

Interventions

Sodium Chloride

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region MidtJylland Denmark

OTHER

Sponsor Role: collaborator

Frank Mose

OTHER

Sponsor Role: lead

Responsible Party

Frank Mose

Clinical Professor, Md. Ph.d.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jesper N. Bech, professor

Role: STUDY_DIRECTOR

University Clinic in Nephrology and Hypertension, Gødstrup Hospital, Hospitalsparken 15, 7400 Herning, Denmark

References

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.

Reference Type: DERIVED

PMID: 40827100 (View on PubMed)

Other Identifiers

1-10-72-351-15

Identifier Type: OTHER

Identifier Source: secondary_id

RLS-1-2015

Identifier Type: -

Identifier Source: org_study_id