Clinical trial NCT02727426: Dietary Salt and Microvascular Function
Official title: Influence of High Salt Diet on Microvascular Reactivity in Young Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Salt; Excess
Keywords: microvascular function
laser Doppler flowmetry
high salt diet
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: microvascular reactivity
timeFrame: two weeks after starting the protocol
Secondary outcomes:
measure: oxidative stress
timeFrame: two weeks after starting the protocol
measure: modification of immunological response by high salt diet
timeFrame: two weeks after starting the protocol
measure: antioxidant capacity
timeFrame: two weeks after starting the protocol
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
Study officials:
affiliation: Faculty of Medicine, University of Osijek, Croatia
name: Ines Drenjancevic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.