Dietary Salt and Microvascular Function

Not Applicable

• Conditions: Salt; Excess

• Registration Number: NCT02727426
• Lead Sponsor: Josip Juraj Strossmayer University of Osijek

Brief Summary

It is well accepted that high-salt (HS) intake is an essential risk factor in development and progression of hypertension. Results of some recent studies suggest that some of the deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may occur in normotensive individuals and are associated with impaired endothelial function. However, the effects of acute salt loading on endothelial function and vascular reactivity in young healthy individuals are still scarce and inconsistent.

The purpose of present study is to determine whether one week of HS intake affects microvascular reactivity in young healthy subjects without changes in BP. In addition, the investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is associated with changes in oxidative stress level and/or with modification of immunological response in young healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-29
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-03
• Study First Posted: 2016-04-04
• Last Update Posted: 2016-04-05
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• oral contraceptives
• drugs that could affect the endothelium
• hypertension
• coronary artery disease
• diabetes
• hyperlipidaemia
• renal impairment
• cerebrovascular and peripheral artery disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
microvascular reactivity	two weeks after starting the protocol	Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperemia- PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation) before and after diet protocols.

Secondary Outcome Measures

Name	Time	Method
antioxidant capacity	two weeks after starting the protocol	As an indicator of antioxidant capacity, the ferric reducing ability of plasma - the FRAP assay (Ferric reducing ability of plasma) with Trolox used as standard (mM Trolox) will be measured before and after LS and HS diet protocol (spectrophotometric method).
oxidative stress	two weeks after starting the protocol	As direct indicator of oxidative stress, byproducts of lipid peroxidation - TBARS method (Thiobarbituric Acid Reactive Substances) with malondialdehyde (MDA) as standard (µM MDA) will be measured before and after LS and HS diet protocol (spectrophotometric method).
modification of immunological response by high salt diet	two weeks after starting the protocol	Activated monocytes/macrophages and neutrophils will be measured by flow cytometry, with distinction of subpopulation of monocytes/macrophages (classical/nonclassical), their activation and the expression of the integrin LFA-1 (lymphocyte function-associated antigen 1) and VLA-4 (Very Late Antigen-4) - ligands VCAM-1 (vascular cell adhesion molecule 1 ) and ICAM-1 (vascular cell adhesion molecule 1).

Trial Locations

Locations (1)

Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology; 🇭🇷 Osijek, Croatia