Dietary Salt and Microvascular Function

Salt; Excess Clinical Trial

Official title:

Influence of High Salt Diet on Microvascular Reactivity in Young Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02727426
• Other study ID #: 215861071012
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2016
• Last updated: April 3, 2016
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Ana - Stupin, MD, PhD
• Phone: +385915134958
• Email: anacavka[@]mefos.hr
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Science, Education and Sports
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Salt; Excess

Intervention

Other:
• Low Salt (LS) diet
Intake of less than 2.3 g of salt per day for 7 days.
• High Salt (HS) diet
Intake of 11.2 g of salt per day for 7 days.

Locations

Country	Name	City	State
Croatia	Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

Cavka A, Cosic A, Grizelj I, Koller A, Jelakovic B, Lombard JH, Phillips SA, Drenjancevic I. Effects of AT1 receptor blockade on plasma thromboxane A2 (TXA2) level and skin microcirculation in young healthy women on low salt diet. Kidney Blood Press Res. 2013;37(4-5):432-42. doi: 10.1159/000355723. Epub 2013 Oct 13. — View Citation

Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7. — View Citation

Cavka A, Jukic I, Ali M, Goslawski M, Bian JT, Wang E, Drenjancevic I, Phillips SA. Short-term high salt intake reduces brachial artery and microvascular function in the absence of changes in blood pressure. J Hypertens. 2016 Apr;34(4):676-84. doi: 10.1097/HJH.0000000000000852. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microvascular reactivity	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.	two weeks after starting the protocol	No
Secondary	oxidative stress	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).	two weeks after starting the protocol	No
Secondary	modification of immunological response by high salt diet	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).	two weeks after starting the protocol	No
Secondary	antioxidant capacity	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).	two weeks after starting the protocol	No