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Dietary Salt and Microvascular Function

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ClinicalTrials.gov Identifier: NCT02727426
Recruitment Status : Unknown
Verified April 2016 by Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek.
Recruitment status was:  Recruiting
First Posted : April 4, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Ines Drenjancevic, 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.


Condition or disease Intervention/treatment Phase
Salt; Excess Other: Low Salt (LS) diet Other: High Salt (HS) diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of High Salt Diet on Microvascular Reactivity in Young Healthy Subjects
Study Start Date : February 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: low salt diet
All subjects will be instructed to maintain a low-sodium (LS) diet, with an intake of less than 2.3 g of salt per day (DASH eating plan; US Department of Health and Human Services, 2006) for 7 days (washout period).
Other: Low Salt (LS) diet
Intake of less than 2.3 g of salt per day for 7 days.

Experimental: high salt diet
After washout period, all subjects will be instructed to maintain a high-sodium (HS) diet, with an intake of 11.2 g of salt per day for 7 days.
Other: High Salt (HS) diet
Intake of 11.2 g of salt per day for 7 days.




Primary Outcome Measures :
  1. microvascular reactivity [ Time Frame: 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 :
  1. oxidative stress [ Time Frame: 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).

  2. modification of immunological response by high salt diet [ Time Frame: 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).

  3. antioxidant capacity [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727426


Contacts
Contact: Ana - Stupin, MD, PhD +385915134958 anacavka@mefos.hr
Contact: Ines - Drenjancevic, MD, PhD +385912241406 ines.drenjancevic@mefos.hr

Locations
Croatia
Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology Recruiting
Osijek, Croatia, 31000
Contact: Ana Stupin, MD, PhD    '385915134598    anacavka@mefos.hr   
Contact: Ines Drenjancevic, MD, PhD    '385912241406    ines.drenjancevic@mefos.hr   
Sponsors and Collaborators
Josip Juraj Strossmayer University of Osijek
Investigators
Principal Investigator: Ines Drenjancevic, MD, PhD Faculty of Medicine, University of Osijek, Croatia