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Clinical Trials/NCT02727426
NCT02727426UnknownNot Applicable

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

Josip Juraj Strossmayer University of Osijek1 site in 1 country50 target enrollmentStarted: February 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
microvascular reactivity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •healthy volunteers

Exclusion Criteria

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

Arms & Interventions

low salt diet

Experimental

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).

Intervention: Low Salt (LS) diet (Other)

high salt diet

Experimental

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.

Intervention: High Salt (HS) diet (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • antioxidant capacity(two weeks after starting the protocol)
  • oxidative stress(two weeks after starting the protocol)
  • modification of immunological response by high salt diet(two weeks after starting the protocol)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ines Drenjancevic

Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Josip Juraj Strossmayer University of Osijek

Study Sites (1)

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