Dietary Salt and Microvascular Function

NCT02727426 | Unknown

• 1 other identifier: 215861071012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Salt; Excess

Keywords

microvascular function; laser Doppler flowmetry; high salt diet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• oxidative stress

  two weeks after starting the protocol

• modification of immunological response by high salt diet

  two weeks after starting the protocol

• antioxidant capacity

  two weeks after starting the protocol

Study Arms (2)

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).

Other: Low Salt (LS) diet

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.

Other: High Salt (HS) diet

Interventions

Low Salt (LS) diet OTHER

Intake of less than 2.3 g of salt per day for 7 days.

low salt diet

High Salt (HS) diet OTHER

Intake of 11.2 g of salt per day for 7 days.

high salt diet

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology

Osijek, 31000, Croatia

RECRUITING

Related Publications (3)

• 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.

  PMID: 26498129 BACKGROUND

• 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.

  PMID: 24247418 BACKGROUND

• 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.

  PMID: 26848993 BACKGROUND

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ines Drenjancevic, MD, PhD

  Faculty of Medicine, University of Osijek, Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana - Stupin, MD, PhD

CONTACT

+385915134958; anacavka@mefos.hr

Ines - Drenjancevic, MD, PhD

CONTACT

+385912241406; ines.drenjancevic@mefos.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 4, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)